Northwestern University Feinberg School of Medicine

Bluhm Cardiovascular Institute - Clinical Trials Unit (CTU)

Clinical Trials

Researchers at the Bluhm Cardiovascular Institute’s Clinical Trials Unit of Northwestern conduct clinical research trials on all aspects of heart and vascular disease.

About Clinical Trials
Clinical trials test or study drugs, surgical procedures, medical devices, or interventions with human subjects. They look to determine their safety and effectiveness in relation to treating specific diseases. Clinical trials are part of clinical research and are at the heart of all medical advances.

Department of Medicine Clinical Trials
The following searchable list includes all Department of Medicine clinical trials currently looking for participants.

Contact Us
For more information about our clinical trials, please contact Anna Huskin at 312-695-4067.

Participant Information

Find information on participating in the research done through the BCVI CTU via our Frequently Asked Questions page.

Trials
CREST-2
Carotid revascularization for primary prevention of stroke (CREST-2) is a multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis. One trial will randomiz…
Carotid revascularization for primary prevention of stroke (CREST-2) is a multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis. One trial will randomize patients in a 1:1 ratio to endarterectomy versus no endarterectomy and another will randomize patients in a 1:1 ratio to carotid stenting with embolic protection versus no stenting. Medical management will be uniform for all randomized treatment groups and will be centrally directed.
Eskandari, MarkEskandari, Mark
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02089217 STU00200290
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Reinkensmeyer, Alexandra Laure
aMAZE Study
This study is a prospective, multicenter, randomized (2:1) controlled study to evaluate the safety and effectiveness of the LARIAT System to percutaneously isolate and ligate the Left Atrial Appendage from the left atrium as an adjunct to planned pulmonary vein isolation (PVI) catheter ab…
This study is a prospective, multicenter, randomized (2:1) controlled study to evaluate the safety and effectiveness of the LARIAT System to percutaneously isolate and ligate the Left Atrial Appendage from the left atrium as an adjunct to planned pulmonary vein isolation (PVI) catheter ablation in the treatment of subjects with symptomatic persistent or longstanding persistent atrial fibrillation. This study will be conducted in two stages: - Limited Early Stage (Stage 1): up to 175 subjects at up to 15 sites - Pivotal Stage (Stage 2): up to 600 subjects at up to 50 sites All patients from both stages will be included in the primary analysis.
Lin, Albert Chao-tunLin, Albert Chao-tun
  • Map it 201 E. Huron St.
    Chicago, IL
NCT04468334 STU00201623
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Carswell, Amy Elizabeth
MISCEND
This study is enrolling patients with moderate to severe mitral regurgitation who are considered to have a high risk for traditional open-heart surgery. Mitral regurgitation, MR, is a condition in which blood flow through the mitral valve flows in the wrong direction during part of the cardia…
This study is enrolling patients with moderate to severe mitral regurgitation who are considered to have a high risk for traditional open-heart surgery. Mitral regurgitation, MR, is a condition in which blood flow through the mitral valve flows in the wrong direction during part of the cardiac cycle, which negatively affects the blood flow to the rest of the body. The purpose of this study is to find out if the mitral valve can be safely replaced using a procedure that is simpler than traditional open-heart procedure and may be safer for patients who are at a higher risk from open-heart surgery. The new device is called the CardiAQ™ Transcatheter Mitral Valve Implantation (TMVI) System (Transseptal and Transapical Delivery Systems). The CardiAQ™ TMVI system is experimental and is not yet approved by the U.S. Food and Drug Administration (FDA) for sale in the United States. This device is implanted without the need for an open-heart procedure and without the need for a heart and lung machine. It is implanted using a delivery catheter, which is a long tube with the valve attached at one end and a handle attached at the other end to control the placement of the valve. The long tube will be inserted through an incision inside the left or right groin (transseptal) or through an incision in the chest between the ribs (transapical). The standard medical treatments generally available to patients with mitral regurgitation who do not undergo surgery may temporarily alleviate some symptoms, but will not permanently alleviate the condition or cure mitral regurgitation. Participation in this study will last for approximately 5 years. Participants will be expected to attend a minimum of 8 scheduled study visits after discharge from the hospital at 1, 3, 6, 12, 24, 36, 48 and 60 months after the procedure.
Patients with moderate to severe mitral regurgitation who are considered to have a high risk for traditional open-heart surgery. General Criteria:
1. Greater than or equal to 18 years of age.
2. New York Heart Associate Classification ≥ II
3. Left Ventricular Ejection Fraction ≥ 30%.
4. Mitral regurgitation (MR) ≥ Grade 3+ (moderate/severe, or severe) where EROA ≥ 0.30 cm2 or VC width ˃ 0.7 cm.
5. Patient is determined to be high surgical risk but operable as assessed by the site’s ‘Heart Team’ (a minimum of one Cardiac Surgeon and one Interventional Cardiologist). Inclusion of a heart failure specialist is strongly recommended.
Davidson, Charles JDavidson, Charles J
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02718001 STU00204104
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Christensen, Lyndsay M.
Gore TAG-TBE
This research study is recruiting patients who have one of the following conditions: 1. A bulge in your aortic wall (aneurysm) caused by weakening in the aortic wall. Over time, this bulge may continue to grow larger and could rupture. 2. A tear in your aortic wall (dissection). Blo…
This research study is recruiting patients who have one of the following conditions: 1. A bulge in your aortic wall (aneurysm) caused by weakening in the aortic wall. Over time, this bulge may continue to grow larger and could rupture. 2. A tear in your aortic wall (dissection). Blood flows through this tear, causing the layers of the aortic wall to separate (dissect) and create a new channel for blood flow. This channel may continue to grow and could rupture. 3. Bleeding and blood clots within your aortic wall (intramural hematoma). This can lead to weakening of the aortic wall and aortic rupture. 4. A lesion (wound) or ulcer in your aortic wall caused by aortic disease and can progress and lead to an aortic aneurysm, dissection, or rupture. 5. A traumatic injury to your aorta that can result in a tear, lesion, or rupture of the aortic wall. The aorta is the main artery in the human body that carries oxygenated blood to all parts of the body. Disease of or injury to the aorta can be a life threatening condition The study will look at treating these aortic diseases and injuries with a new medical device called the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device). Depending on the location of your aortic disease or injury, the study device will be implanted inside your aorta and one of the main arteries that branches off your aorta supply blood to the brain and arms. Study participants will be expected to return for follow-up visits with the Study Doctor at one (1), six (6), 12, 24, 36, 48, and 60 months following the procedure. This research study plans to enroll up to 435 study participants at approximately 40 sites across the country, including up to 5 people from this institution.
Primary Inclusion Criteria:

  • Presence of thoracic aortic pathology deemed to warrant surgical repair which requires proximal graft placement in Zone 0-2.
  • Age ≥18 years at time of informed consent signature Subject is capable of complying with protocol requirements, including follow-up Informed Consent Form (ICF) is signed by Subject or legal representative
  • Must have appropriate proximal aortic landing zone
  • Must have appropriate target branch vessel landing zone For patients with aneurysm/isolated lesion
  • Must have appropriate distal aortic landing zone.
Primary Exclusion Criteria:

  • Concomitant disease of the ascending aorta or aneurysm of the abdominal aorta requiring repair
  • Previous endovascular repair of the ascending aorta
  • Previous endovascular repair of the DTA with a non-Gore device
  • Surgery within 30 days prior to enrollment
  • Myocardial infarction within 6 weeks prior to treatment
  • Stroke within 6 weeks prior to treatment.

Hoel, Andrew WarfieldHoel, Andrew Warfield
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02777593 STU00203850
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Reinkensmeyer, Alexandra Laure
Bolton RelayPro
This study is recruiting patients who have an acute (very sudden onset or rapid change, within 2 weeks), complicated type B aortic dissection. One way to repair an acute, complicated type B aortic dissection is with an endovascular stent-graft. A stent-graft is a polyester fabric tu…
This study is recruiting patients who have an acute (very sudden onset or rapid change, within 2 weeks), complicated type B aortic dissection. One way to repair an acute, complicated type B aortic dissection is with an endovascular stent-graft. A stent-graft is a polyester fabric tube (graft) sewn onto metal springs (stent). The stent-graft is compressed inside a narrow plastic tube called a delivery system, which is inserted into the blood vessels in the groin area (femoral/iliac artery) and then threaded through the blood vessels to be placed at the area of the dissection inside the aorta.This research study will assess and evaluate safety and performance of an endovascular stent graft called the RelayPro Thoracic Stent-Graft System (the “Study Device”). The Study Device is investigational, which means it is still being tested and is not approved by the Food and Drug Administration (FDA) for sale in the United States.We expect that participants will be in this research study for approximately 5 years after their endovascular repair procedure. Participants will return to clinic at 1-month, 6-months, and 1-year, and then annually out to 5 years. These visits are considered part of standard care, and the results of test done at these visits will be recorded for the study.We expect up to 5 people here will be in this research study out of 80 people in the entire study nationally.
Inclusion Criteria:

  • Subject must have an acute (symptom onset to diagnosis within 2 weeks) or
  • Subacute, complicated type B aortic dissection
  • Proximal and distal aortic neck with diameter between 19 mm and 42 mm.
Exclusion Criteria:

  • Diagnosis of traumatic injury or transection of the descending thoracic aorta.
  • Significant stenosis, calcification, thrombus, or tortuosity of intended fixation sites that would compromise fixation or seal of the device.
  • Planned coverage of left carotid or celiac arteries; or anatomic variants that would compromise circulation to the carotid, vertebral, or innominate arteries after device placement, which is not amenable to subclavian revascularization.
  • Prior endovascular or surgical repair in the descending thoracic aorta.

Malaisrie, S ChrisMalaisrie, S Chris
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03033043 STU00204570
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Warzecha, Anna
P3 AVIV Registry
This study will evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) Model 9600TFX and associated delivery systems for the aortic valve in valve procedure. Participants in this study will have the investigational (experimental) Edwards SAPIE…
This study will evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) Model 9600TFX and associated delivery systems for the aortic valve in valve procedure. Participants in this study will have the investigational (experimental) Edwards SAPIEN 3 transcatheter aortic heart valve (study device) to replace the failing bioprosthetic aortic valve access through the heart through a small incision is in the chest. The study device and its delivery system are investigational, which means they are not approved for commercial use by the U.S. Food and Drug Administration (FDA) for the valve in bioprosthetic valve procedure. The previous generation of SAPIEN valves, SAPIEN XT, was approved for commercial use by the FDA for a failed surgical bioprosthetic aortic valve in October 2015. The study device is a bioprosthetic heart valve made out of man-made materials and animal tissue. It is an artificial device made to replace the diseased aortic heart valve. Each valve consists of a stent (mesh tube made of metal) to hold the study device in its intended position and valve leaflets (made of biological material derived from cows) to direct the flow of blood in the heart. Study participation will last approximately 10 years. Participants will be asked to come to clinic for study visits at 30 days, 6 months, and 12 months after the study procedure and then annually until 10 years after the procedure. We expect up to 19 people will be enrolled at Northwestern. The study expects to enroll up to 125 people internationally.
*Main Inclusion Criteria*
Failing surgical or transcatheter bioprosthetic valve in the aortic position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.

*Main Exclusion Criteria*
Surgical or transcatheter valve in the mitral position (mitral rings are not an exclusion).
Severe regurgitation (>3+) or stenosis of any other valve.
Failing valve is unstable, rocking, or not structurally intact.
Malaisrie, S ChrisMalaisrie, S Chris
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03003299 STU00204739
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Kats, Lauren E
Activity and AS
This trial is enrolling patients who have aortic stenosis and are undergoing a transcatheter aortic valve replacement or a surgical aortic valve replacement. This research is being performed to evaluate wearable activity monitors (specifically, FitBits will be used) in patients…
This trial is enrolling patients who have aortic stenosis and are undergoing a transcatheter aortic valve replacement or a surgical aortic valve replacement. This research is being performed to evaluate wearable activity monitors (specifically, FitBits will be used) in patients with aortic stenosis undergoing a procedure to fix their aortic stenosis. Many patients with aortic stenosis have low activity levels which improve after undergoing a procedure to fix their aortic stenosis, but the current methods used to assess activity levels are limited. This study will use a unique method (wearable activity monitors) to continuously track activity, both before and after the procedure. We are interested in comparing this method to the traditional methods used, which includes a 6 minute walk test and an assessment of the ability to engage in physical activity as determined by study coordinators and/or the physician through a conversation with patients. We are also

interested in assessing quality of life through surveys to determine how that relates to activity data.

Davidson, Charles JDavidson, Charles J
  • Map it 201 E. Huron St.
    Chicago, IL
STU00204803
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Kats, Lauren E
EARLY TAVR
The main reason for the study is to determine whether aortic valve replacement with the Edwards SAPIEN 3 THV (the “Study Device”) is helpful for patients who have severe, calcific, aortic stenosis (a narrowing of the aortic heart valve, where calcium has attached to the valve surface, …
The main reason for the study is to determine whether aortic valve replacement with the Edwards SAPIEN 3 THV (the “Study Device”) is helpful for patients who have severe, calcific, aortic stenosis (a narrowing of the aortic heart valve, where calcium has attached to the valve surface, resulting in obstructed blood flow) and do not have symptoms. The Study Device is a bioprosthetic heart valve. It is an artificial device made to replace your diseased aortic heart valve. Each valve consists of a stent (mesh tube made of metal) to hold the valve in position and valve leaflets (made of biological material derived from cows) to direct the flow of blood in your heart. The Study Device and its delivery system are not approved for commercial use by the U.S. Food and Drug Administration (FDA) in patients that do not have symptoms of aortic stenosis. To date, more than 12,000 patients have been enrolled in clinical studies with an Edwards THV. The SAPIEN 3 THV that is being investigated for this study has been implanted in over 3,000 patients with symptoms of severe aortic stenosis and has been approved by FDA for those patients. Participation in the study will vary, depending upon the treatment group you are assigned. If you are in the TAVR group, your participation will be for 5 years. If you are in the Clinical Surveillance group, your participation could range from 5 to 10 years. If you are in the registry group, your participation will be for 5 years. We expect up to 166 people will participate in the main study and up to up to 150 in the registry here at Northwestern. A total of 1109 patients will participate in the main study and up to 1000 patients will participate in the registry internationally.
Inclusion Criteria:
Severe aortic stenosis
Patient is asymptomatic
The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the institutional review board of the respective clinical site.

Exclusion Criteria:
Patient is symptomatic.
Ilio-femoral vessel characteristics that would preclude safe placement of the introducer sheath.
Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization.
Aortic valve is a unicuspid, bicuspid, or is non-calcified.
Severe aortic regurgitation (>3+).
Severe mitral regurgitation (>3+) or ≥ moderate mitral stenosis.
Davidson, Charles JDavidson, Charles J
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03042104 STU00204517
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Kats, Lauren E
APOLLO TMVR
This study is enrolling subjects with moderate-to-severe symptomatic mitral regurgitation to test a new investigational device for mitral regurgitation. The new investigational device is a mitral valve replacement called the IntrepidTM Transcatheter Mitral Valve Replacement (TMVR) System…
This study is enrolling subjects with moderate-to-severe symptomatic mitral regurgitation to test a new investigational device for mitral regurgitation. The new investigational device is a mitral valve replacement called the IntrepidTM Transcatheter Mitral Valve Replacement (TMVR) System. The purpose of the TMVR device is to function similarly to a standard bioprosthetic (man-made) valve implant in that it allows blood to flow only in the forward direction, relieving mitral regurgitation. A standard valve implant, however, is sewn directly into the heart during surgery in which the chest is fully open, the patient is put on heart-lung bypass support and the heart is temporarily stopped to sew in the valve. The TMVR device is intended to be placed through a less invasive procedure, without sewing, and without requiring heart-lung bypass support or stopping the heart.
Enrolling participants with mitral valve regurgitation that are at high risk of experiencing major complications while undergoing open-heart surgery due to their current medical conditions or anatomical reasons (relating to how and where the heart, mitral valve, and blood vessels are placed within the body). Additionally, physicians determined condition may not be optimally treated with currently approved transcatheter repair therapies.
Malaisrie, S ChrisMalaisrie, S Chris
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03242642 STU00206197
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Christensen, Lyndsay M.
AF-STOP
To improve the understanding of factors associated with the atrial myopathy in people with AF or people at risk for developing AF
Primary Inclusion Criteria:
  • Patients ≥ 18 years old
  • Patients with paroxysmal or early persistent AF undergoing routine pulmonary vein isolation (PVI)
  • Subjects who are scheduled to undergo clinically ordered cardiac MRI for planning of AF ablation

Primary Exclusion Criteria:

  • Longstanding persistent AF (continuous AF > 1 year) or AF from a reversible cause
  • Previous catheter or surgical ablation for AF
  • Contraindication to MRI
  • Advanced chronic renal insufficiency (GFR < 30 mL/min/1.73 m2), anemia (hemoglobin < 10 g/dL) or thrombocytopenia (platelet count < 100K/UL)
  • History of pulmonary emboli, CVA or TIA (within the past 6 months), atrial clot/thrombus on imaging, or blood clotting/bleeding abnormalities
Passman, Rod SPassman, Rod S
  • Map it 201 E. Huron St.
    Chicago, IL
STU00207885
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Whisler, Cailin Elizabeth
CLASP IID/IIF
The objectives of this pivotal clinical trial are to evaluate the safety and effectiveness of the PASCAL System for transcatheter mitral valve repair compared to the MitraClip system in the treatment of patients with symptomatic degenerative mitral regurgitation (DMR) and who have been …
The objectives of this pivotal clinical trial are to evaluate the safety and effectiveness of the PASCAL System for transcatheter mitral valve repair compared to the MitraClip system in the treatment of patients with symptomatic degenerative mitral regurgitation (DMR) and who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team.

Primary Inclusion Criteria:

  • Patient is determined to be at prohibitive risk for mitral valve surgery by a heart team
  • Mitral regurgitation (3+ to 4+) by echo (TTE or TEE) as measured by the core lab
  • Left ventricular ejection fraction (LVEF) ≥ 20%
  • Davidson, Charles JDavidson, Charles J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03706833 STU00208635
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    Kats, Lauren E
    TAVR UNLOAD
    The purpose of this study is to evaluate the use of a device to treat patients with Heart Failure (HF - inability of the heart to pump enough blood to meet the body's needs) who have moderate aortic stenosis (AS - narrowing of the aortic valve resulting in obstructed blood flow). …

    The purpose of this study is to evaluate the use of a device to treat patients with Heart Failure (HF - inability of the heart to pump enough blood to meet the body's needs) who have moderate aortic stenosis (AS - narrowing of the aortic valve resulting in obstructed blood flow). This clinical trial is comparing the safety and effectiveness of TAVR (Transcatheter Aortic Valve Replacement) with the Edwards SAPIEN 3 Transcatheter Heart Valve (the Study Valve) and OHFT (optimal heart failure therapy) versus OHFT alone in HF patients with moderate AS. The study valve has not been approved by the U.S. Food and Drug Administration (FDA) for use in this patient population, and therefore it's use in this study is considered investigational.
    This study is looking for patients with Heart Failure and moderate Aortic Stenosis. Aortic Stenosis is a narrowing of the aortic valve opening,which blocks blood flow from the heart and causes symptoms such as chest pain,fainting and shortness of breath.
    Davidson, Charles JDavidson, Charles J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02661451 STU00208415
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    Kats, Lauren E
    ICE AFIB IDE Study
    This study is enrolling patients who have been diagnosed with a non-paroxysmal form of atrial fibrillation (persistent or longstanding persistent) and whose doctor determined that they need surgery to correct their AF, along with another heart problem (i.e., heart valve or blocked …
    This study is enrolling patients who have been diagnosed with a non-paroxysmal form of atrial fibrillation (persistent or longstanding persistent) and whose doctor determined that they need surgery to correct their AF, along with another heart problem (i.e., heart valve or blocked artery). Atrial fibrillation (AF) is an irregular heartbeat, which may cause symptoms such as pounding sensations in the chest, dizziness, fatigue, chest pain, and/or shortness of breath. People may participate in this clinical research trial if their study doctor has determined that they have a certain type of AF and require surgery to correct another heart problem other than AF. The purpose of this study is to evaluate safety and effectiveness of the cryoICE Cryoablation System, in conjunction with LAA exclusion using the AtriClip device, in patients with persistent or longstanding persistent atrial fibrillation who are having heart surgery for another reason. AtriCure’s cryoICE Cryoablation System has been cleared by the FDA to ablate cardiac tissue for the treatment of non-specific cardiac arrhythmias in patients who are undergoing open heart surgery. However, the cryoICE Cryoablation System is not approved by the FDA specifically for the treatment of atrial fibrillation and therefore its use is considered investigational in this study.
    McCarthy, Patrick MMcCarthy, Patrick M
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03732794 STU00209056
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    Warzecha, Anna
    VENUS-HF
    This study is enrolling patients who have Acute Decompensated Heart Failure (ADHF) and are having or recently had a cardiac catheterization procedure as part of their clinical care (not part of the research).The reason we are doing this research study is to look at the preCARDIA device (the …
    This study is enrolling patients who have Acute Decompensated Heart Failure (ADHF) and are having or recently had a cardiac catheterization procedure as part of their clinical care (not part of the research).The reason we are doing this research study is to look at the preCARDIA device (the “study device”) to see if it can help treat Advanced Heart Failure. This type of research study is called an “early feasibility study”. Early feasibility studies typically evaluate innovative devices or innovative uses of approved devices. These studies enroll a small number of participants and provide initial information on the basic safety and performance of the study device when used to treat a specific patient type. The study device is investigational and not approved by the US Food and Drug Administration (FDA) for your medical condition. In patients with advanced heart failure, specifically severely congested patients with Acute Decompensated Heart Failure (ADHF), poor heart function leads to an excess of fluid in the right side of the heart (“fluid overload”) and symptoms such as shortness of breath. Drugs such as diuretics are designed to improve these symptoms and heart function by reducing fluid overload. However, diuretics take time to work and may be ineffective in patients with advanced heart failure, a phenomenon known as diuretic resistance. For this reason, a device-based approach designed to limit fluid overload is being studied to see if it could possibly improve symptoms and heart function in congested patients with advanced heart failure. The study device will temporarily block (“occlude”) one of the veins that return blood to the heart in order to potentially reduce fluid buildup and potentially improve the heart’s pumping function temporarily.
    Benzuly, Keith HBenzuly, Keith H
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03836079 STU00210029
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    Roshevsky, Daniel Scott
    Esophageal Temperature Management During Cryo AF Ablation
    This study is enrolling patient who have an irregular heart rhythm called atrial fibrillation (AF) and are scheduled for a first-time AF ablation procedure to treat their AF. Current techniques used during AF ablation procedures to try and red…
    This study is enrolling patient who have an irregular heart rhythm called atrial fibrillation (AF) and are scheduled for a first-time AF ablation procedure to treat their AF. Current techniques used during AF ablation procedures to try and reduce potential damage to the esophagus during ablation are limited. The purpose of this study is to determine if esophageal warming using the Attune Medical Esophageal Heat Transfer Device (ensoETM) limits the injury to the esophagus during atrial fibrillation ablation procedures. The ensoETM is an FDA approved device used for temperature management, but is not routinely used during atrial fibrillation ablation procedures.
    Verma, NishantVerma, Nishant
    • Map it 201 East Huron Street Suite 12-160​
      Chicago, IL
    NCT04079634 STU00209610
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    Canino, Courtney Victoria
    GORE GSO 18-01 (REDUCE PAS)
    This study is enrolling patients who have a patent foramen ovale (PFO), have had a stroke of unknown origin (cryptogenic stroke), and whose doctor has decided they are a candidate for a transcatheter procedure (a procedure performed through a flexible tube inserted through…
    This study is enrolling patients who have a patent foramen ovale (PFO), have had a stroke of unknown origin (cryptogenic stroke), and whose doctor has decided they are a candidate for a transcatheter procedure (a procedure performed through a flexible tube inserted through a narrow opening into a small incision in the skin) to close their PFO. A PFO is a common opening in the wall (septum) between the two upper chambers (the right and left atria) of your heart. In most cases, this opening closes around the time of birth. If the opening remains after birth, it can allow the blood to mix in the two upper chambers of the heart. This post-market study will look at closing the PFO to reduce the risk for another stroke using a market-approved medical device called a septal occluder. This device is called the ‘GSO device’ in this description. The GSO device is a minimally invasive device intended for the closure of a PFO using cardiac catheterization. It is a permanent implant consisting of a near circular wire frame covered with thin material. The soft, conformable material, invented and manufactured by Gore, has been used in open-heart surgery for more than 40 years and has been shown to be safe in implanted medical devices. The wire frame is made of a nickel-titanium metal alloy called nitinol with a platinum core (so that it may be seen on X-ray images).
    Benzuly, Keith HBenzuly, Keith H
    • Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100
      Chicago, IL
    NCT03821129 STU00209945
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    PFO PFO Closure

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    Roshevsky, Daniel Scott
    RADIANCE II
    This study is enrolling patients who have high blood pressure ("hypertension") and are taking two medications or fewer for it. It is believed that in some patients with high blood pressure, the nerves surrounding the blood vessels leading to the kidneys (renal arteries) are too active and…
    This study is enrolling patients who have high blood pressure ("hypertension") and are taking two medications or fewer for it. It is believed that in some patients with high blood pressure, the nerves surrounding the blood vessels leading to the kidneys (renal arteries) are too active and that this may be causing high blood pressure. Renal denervation is a procedure where a catheter is placed inside these blood vessels and creates heat to disable the nerves and potentially lower blood pressure. The purpose of this clinical study is to see whether a medical device called the Paradise Renal Denervation System (also called The Paradise System) can lower high blood pressure in patients who are known to have hypertension.
    Benzuly, Keith HBenzuly, Keith H
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03614260 STU00209790
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    Hypertension HTN

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    Canino, Courtney Victoria
    CLASP II TR Pivotal
    This study is enrolling patients with severe Tricuspid Regurgitation (TR), a condition in the heart’s tricuspid valve does not close tightly which causes the blood to flow in the wrong direction. The standard medical treatments generally available to patients with tricuspid regu…
    This study is enrolling patients with severe Tricuspid Regurgitation (TR), a condition in the heart’s tricuspid valve does not close tightly which causes the blood to flow in the wrong direction. The standard medical treatments generally available to patients with tricuspid regurgitation who do not undergo surgery, may temporarily alleviate some symptoms, but will not permanently alleviate or cure tricuspid regurgitation.  The goal of this trial is to evaluate the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System (hereinafter referred to as the PASCAL System) with optimal medical therapy (OMT) compared to OMT alone in the treatment of participants with symptomatic severe tricuspid regurgitation who may not be ideal candidates for tricuspid valve surgery (performed via open-heart surgery) and may be eligible for transcatheter tricuspid valve repair (minimally invasive procedure that repairs the valve). Optimal Medical Therapy (OMT) refers to standard of care treatment using recommended medications
    Davidson, Charles JDavidson, Charles J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04097145 STU00211052
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    McCloskey, Elizabeth Marie
    RV Ischemia & Fibrosis in CTEPH
    This study is enrolling patients who have been diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH) and who are scheduled for a pulmonary endareterectomy (PEA) or balloon pulmonary angioplasty (BPA) procedure for treatment. CTEPH is high b…
    This study is enrolling patients who have been diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH) and who are scheduled for a pulmonary endareterectomy (PEA) or balloon pulmonary angioplasty (BPA) procedure for treatment. CTEPH is high blood pressure in the arteries in the pulmonary system (lungs) caused by clots. Over time the clots typically leave scar tissue (fibrosis) in the arteries and lead to poor blood supply to the heart. In patients with CTEPH symptoms of heart failure commonly result from dysfunction (not working correctly) in the right ventricle (RV), or the chamber of the heart that pumps blood to the lungs. However, little is currently known about why or how that chamber of the heart becomes dysfunctional in patients with this condition. In another chamber of the heart, the left ventricle, it is known that elevated blood pressure in that chamber causes the development of diffuse fibrosis, or scarring between the muscle fibers, and a similar process may take place in the right ventricle of patients with CTEPH.

    For this study a cardiac magnetic resonance imaging (MRI) stress test (also known as stress CMR) will be done to look at the RV in patients with CTEPH before and 6 months after treatment. A stress CMR is a specialized scan of the heart that examines fibrosis (scarring) and blood flow (perfusion) both at rest and under stress. A gadolinium contrast agent (MRI dye) is given to highlight the heart muscle in areas receiving a good blood supply. Areas receiving less blood do not highlight as well as the good areas, which can be an indicator of ischemic heart disease (undersupply of blood and oxygen to the heart).

    Freed, Benjamin HowardFreed, Benjamin Howard
    • Map it 201 East Huron Street Suite 12-160​
      Chicago, IL
    STU00210998
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    Whisler, Cailin Elizabeth
    HAPI-HF
    This study is enrolling patients to use a wearable insertable cardiac monitor to better understand the various sounds that the heart makes during cardiac tests. You are being asked to participate in this study because Boston Scientific Corporation (BSC) is making a device called the insertabl…
    This study is enrolling patients to use a wearable insertable cardiac monitor to better understand the various sounds that the heart makes during cardiac tests. You are being asked to participate in this study because Boston Scientific Corporation (BSC) is making a device called the insertable cardiac monitor (ICM) that measures certain heart functions. The device also works when it is placed on top of the chest. BSC made a more comfortable, wearable version of the device to use in this study. The wearable device is called the wearable cardiac monitor (WCM). As part of the study, the WCM will collect data during tests while taped to the skin. The tests include leg raise exercises, lying down, sitting and/or standing, and an optional submaximal exercise test for participants the study doctor determines appropriate. There may also be an echocardiogram during these tests. An echocardiogram takes pictures of the heart using sounds waves created by the heart. The purpose of this study is to collect data during a series of tests to see if the WCM can detect signals related to heart failure. This data will be compared to the data obtained by the echocardiogram.
    Shah, Sanjiv JShah, Sanjiv J
    • Map it 251 E. Huron St.
      Chicago, IL
    NCT04112576 STU00210829
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    Ganz, Stephanie
    EV ICD
    This study is enrolling patients who have or may experience abnormal heart rhythms and whose doctor recommends that they undergo a medical procedure to implant a device called an implantable cardioverter defibrillator (ICD). An ICD is a device that monitors and treats abnormal heart rhythms. T…
    This study is enrolling patients who have or may experience abnormal heart rhythms and whose doctor recommends that they undergo a medical procedure to implant a device called an implantable cardioverter defibrillator (ICD). An ICD is a device that monitors and treats abnormal heart rhythms. This study is testing a new treatment for abnormal heart rhythms, called the Medtronic Extravascular (EV ICD) system. Patients who agree to be in this study, and meet the study inclusion requirements, will receive the Medtronic EV ICD system. The purpose of this study is to evaluate how safe the Study System is and how well the Study System works.
    Lin, Albert Chao-tunLin, Albert Chao-tun
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04060680 STU00211292
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    Carswell, Amy Elizabeth
    TAMBE Pivotal AAA 17-01
    This study is enrolling patients who have an aortic aneurysm involving the visceral branch blood vessels (vessels that provide blood to the kidneys) that requires treatment. The aorta is a large blood vessel that carries blood away from the heart to organs in the rest of the b…
    This study is enrolling patients who have an aortic aneurysm involving the visceral branch blood vessels (vessels that provide blood to the kidneys) that requires treatment. The aorta is a large blood vessel that carries blood away from the heart to organs in the rest of the body. This research study will look at treating thoracoabdominal or pararenal aneurysm disease with a new device design known as the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (the ‘Study Device’).The Study Device that will be used to treat the aneurysm is called a “stent-graft”. The Study Device combines a surgical graft material with an outer metal mesh-like form (stent). The nonmetal graft component of the Study Device is made of a soft, polymer material (ePTFE). This material is routinely and safely used for surgical procedures throughout the world today. The graft is surrounded on the outside with a metal frame made from an elastic metal (nitinol wire or stainless steel) bent into a wave pattern and shaped to fit the graft. The materials used in the Study Device are not investigational and have a long, safe history of performance in similar applications.
    Hoel, Andrew WarfieldHoel, Andrew Warfield
    • Map it 201 East Huron Street Suite 12-160​
      Chicago, IL
    NCT03728985 STU00211408
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    Reinkensmeyer, Alexandra Laure
    REPAIR-MR
    The purpose of this research study is to compare health outcomes of patients diagnosed with Primary MR who have their MV repaired with open heart surgery, which is the current standard treatment, to patients who have their Mitral Valve repaired with the MitraClip System…
    The purpose of this research study is to compare health outcomes of patients diagnosed with Primary MR who have their MV repaired with open heart surgery, which is the current standard treatment, to patients who have their Mitral Valve repaired with the MitraClip System. The MitraClip System uses a less invasive procedure to repair the mitral valve.

    Subjects are asked to participate in this Study because they have moderate-to-severe or severe MR and it has been determined to have symptoms due to heart failure despite being treated with currently available therapies. MR occurs when the leaflets of the mitral valve do not close properly causing blood to leak backward with each heartbeat. Since some of the blood leaks backward, the heart needs to pump more blood with each beat to push the same amount of blood forward.

    The Study will enroll approximately 500 subjects at up to 60 sites in Europe, United States, and Canada. The Study consists of two arms: Device Arm and Control Arm.

    • Subject has severe (Grade III or greater per the ASE criteria, which includes severitygrades of 3+ and 4+) primary MR (mixed etiology is acceptable provided theprincipal mechanism of action is a degenerative mitral valve) as assessed bythe ECL.
    • Subject is at least 75 years of age

    Davidson, Charles JDavidson, Charles J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04198870 STU00211557
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    Kats, Lauren E
    TRILUMINATE
    The purpose of this research study is to compare the safety and effectiveness of an investigational tricuspid valve repair system, called TriClip TM Device, which is inserted into the heart, along with using optimal drug therapy for your heart condition versus optimal drug therapy alone. …
    The purpose of this research study is to compare the safety and effectiveness of an investigational tricuspid valve repair system, called TriClip TM Device, which is inserted into the heart, along with using optimal drug therapy for your heart condition versus optimal drug therapy alone. The Study will enroll approximately 700 subjects at up to 80sites in Europe, United States and Canada. Up to 50 participants will be enrolled at Northwestern. The Study is made up of three different groups: Randomized(up to 450), Roll-In (up to 150, and Single-Arm Registry (up to 100).
    • Age ≥18 years at time of consent.
    • Subject has been diagnosed with moderate or greater tricuspid regurgitation determined to have symptoms due to heart failure despite being treated with currently available therapies
    Davidson, Charles JDavidson, Charles J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03904147 STU00210487
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    McCloskey, Elizabeth Marie
    Cytokinetics CY 6021
    This study is enrolling patients who have obstructive hypertrophic cardiomyopathy (oHCM). Obstructive HCM is a condition in which the heart muscle in the left ventricle (LV) becomes abnormally thickened, which can block blood flow out of the heart to the body. This obstruction ca…
    This study is enrolling patients who have obstructive hypertrophic cardiomyopathy (oHCM). Obstructive HCM is a condition in which the heart muscle in the left ventricle (LV) becomes abnormally thickened, which can block blood flow out of the heart to the body. This obstruction causes the LV heart muscle to work harder to pump blood to the body and can cause symptoms of chest pain, dizziness, shortness of breath and fainting. This is the first time the investigational drug called CK-3773274 is being studied in participants who have oHCM, but it has already been studied in healthy volunteers. The purpose of this study is to learn how well CK-3773274 is tolerated at different, increasing dose levels in patients with oHCM and if it causes any side effects. The study will also measure the amount of CK-3773274 in your blood at various times, and the effect the study drug may have on your oHCM. CK-3773274 is an investigational (experimental) study drug. This means that CK-3773274 has not been approved by the U.S. Food and Drug Administration (FDA) for use outside of a research study.
    Choudhury, LubnaChoudhury, Lubna
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04219826 STU00211491
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    Rasberry, Kiersten Alexandria
    ION-682884-CS2 cardioTTRansform
    This study is enrolling patients who have transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) which is a disease caused by change in a protein called transthyretin (TTR). This change can either be sporadic which is known as wild-type (wtATTR-CM) or due to a mutatio…
    This study is enrolling patients who have transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) which is a disease caused by change in a protein called transthyretin (TTR). This change can either be sporadic which is known as wild-type (wtATTR-CM) or due to a mutation of the TTR gene which is hereditary (hATTR-CM). In both cases, these changes can cause the TTR to clump and build up in certain parts of the body such as the nervous system, stomach, intestines, and heart. This build up is called an amyloid deposit. Amyloid deposits can sometimes cause heart disease or neuropathy (nerve damage). When amyloid is deposited into the heart, it can result in a condition referred to as cardiomyopathy. ION-682884 is an investigational drug. “Investigational” means that ION-682884 is not yet approved for use in any settings outside of clinical research studies like this one and is considered experimental. ION-682884 reduces the level of TTR in the blood of animals and healthy volunteers tested to date. Reducing the amount of TTR in the blood may reduce the amount of amyloid deposits in the body and may keep cardiomyopathy from getting worse over time. However, it is not known if ION-682884 will help cardiomyopathy. The purpose of this study is to evaluate the safety of ION-682884 and determine if it can help people with this type of cardiomyopathy.
    Shah, Sanjiv JShah, Sanjiv J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04136171 STU00211443
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    Sanchez, Cynthia L
    The BASIC Study
    This study is enrolling patients who have been referred for a treadmill exercise stress test. The purpose of this study is to see if there is a relationship between the chemicals and proteins found in human blood and urine and those found in human sweat. The study will also loo…

    This study is enrolling patients who have been referred for a treadmill exercise stress test. The purpose of this study is to see if there is a relationship between the chemicals and proteins found in human blood and urine and those found in human sweat. The study will also look to see how the chemicals and proteins in human blood, urine, and sweat may change depending on if a person is at rest or doing a stressful activity such as exercising on a treadmill.

    Pandit, Jay APandit, Jay A
    • Map it 25 N. Winfield Road
      Winfield, IL
    STU00212287
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    Petersen, Julie A
    PROACT Xa
    This study is enrolling patients who had an On-X mechanical valve implanted in the aortic position at least 3 months (90 days) ago, are currently receiving warfarin anticoagulation, and are able to receive warfarin with a target INR (measurement of how long it takes for blood to form a clot…
    This study is enrolling patients who had an On-X mechanical valve implanted in the aortic position at least 3 months (90 days) ago, are currently receiving warfarin anticoagulation, and are able to receive warfarin with a target INR (measurement of how long it takes for blood to form a clot) of 2.0 to 3.0.  Studies have shown that patients who get tissue valves instead of mechanical valves (On-X Prosthetic Heart Valve / On-X valve) usually have to be operated on again. However, patients who get mechanical valves need to take warfarin for anticoagulation (helps to avoid blood clotting on or near the valve) and maintaining appropriate levels of warfarin can be hard to manage. Some patients may be too responsive to warfarin or not responsive enough. Some patients are allergic to warfarin. A larger number of patients have a hard time keeping warfarin control because of how warfarin interacts with other drugs or certain foods. Another reason people don’t want to take warfarin is because of the need for frequent blood testing. Thus, some patients choose tissue valves over mechanical valves even though studies show the outcomes are worse because the patients do not want to have to take warfarin because it can be hard to manage.
    • Male or female at least 18 years of age at the time of giving informed consent.
    • Participants currently receiving warfarin anticoagulation and who are able to receive warfarin with a target INR 2.0 to 3.0.
    Malaisrie, S ChrisMalaisrie, S Chris
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04142658 STU00211882
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    Warzecha, Anna
    ALL-IN
    This study is enrolling patients who are about to have a heart transplant. After transplantation, or any other major surgery, there will be inflammation in the body. This inflammation can contribute to rejection of the transplanted heart. In addition, the immune system (your body’s de…

    This study is enrolling patients who are about to have a heart transplant. After transplantation, or any other major surgery, there will be inflammation in the body. This inflammation can contribute to rejection of the transplanted heart. In addition, the immune system (your body’s defenses to protect against disease) will be activated by the presence of the new heart. Investigators believe that a drug called tocilizumab (ACTEMRA®) might reduce or prevent inflammation and reduce the immune system’s response to the new heart, and that this would improve the long-term health of your new heart. The purpose of this research study is to see if a study drug called Actemra® (tocilizumab) will, when given with standard anti-rejection medicines, lead to better heart transplantation outcomes at 1 year after the transplant. Tocilizumab is a prescription medicine approved by the US Food and Drug Administration (FDA) to treat rheumatoid arthritis (RA) and other inflammatory diseases. Tocilizumab has not been used before to treat people who receive a heart transplant. We don’t know if it will be good for people who have a heart transplant. Tocilizumab is not approved by the FDA to treat heart transplant patients, and therefore using it in this study is considered investigational.

    Ghafourian, KambizGhafourian, Kambiz
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03644667 STU00212222
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    Roshevsky, Daniel Scott
    CECs as Biomarkers of CV Events in COVID-19
    This study is recruiting patients who have been admitted to the hospital with a diagnosis of COVID-19. The purpose of this research study is to look at a new marker of inflammation that may predict worsening clinical parameters or severe disease in patients…
    This study is recruiting patients who have been admitted to the hospital with a diagnosis of COVID-19. The purpose of this research study is to look at a new marker of inflammation that may predict worsening clinical parameters or severe disease in patients with COVID-19
    Akhter, NausheenAkhter, Nausheen
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00212691
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    Ramirez, Haydee
    ATTR-CM Machine Learning
    This study is enrolling patients who have a diagnosis of congestive heart failure in their medical record, and is interested in determining whether one can use an automated, computer-based method to diagnose a specific cause of heart failure (“transthyretin cardiac a…

    This study is enrolling patients who have a diagnosis of congestive heart failure in their medical record, and is interested in determining whether one can use an automated, computer-based method to diagnose a specific cause of heart failure (“transthyretin cardiac amyloidosis”) based on other diagnoses in the medical record. Transthyretin cardiac amyloidosis is a rare disease that results from a protein in the body that becomes misfolded and starts depositing into the heart, a process known as amyloidosis. Because of these proteins getting into the heart muscle, the heart can get stiff and weak, thereby leading to congestive heart failure. Typically this form of heart disease (cardiac amyloidosis) is diagnosed late in its course and it associated with poor survival. However, there are now treatments for this disease, so earlier diagnosis is better. A machine learning (artificial intelligence)-based method to find potential patients with cardiac amyloidosis has been developed. This computer program automates finding patients who may have cardiac amyloidosis based on their other diagnoses in the electronic health record. This study seeks to validate the computer algorithm prospectively to see if it can be useful in patients to determine whether or not cardiac amyloidosis is the cause of heart failure.

    Shah, Sanjiv JShah, Sanjiv J
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00211906
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    Ramirez, Haydee
    STOP Severe COVID-19
    This study is enrolling patients at Northwestern Memorial Hospital who have tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) or coronavirus disease 2019 (COVID-19) and require oxygen support. Doctors at Northwestern University want to better underst…
    This study is enrolling patients at Northwestern Memorial Hospital who have tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) or coronavirus disease 2019 (COVID-19) and require oxygen support. Doctors at Northwestern University want to better understand if blocking a molecule in the blood, plasminogen activator inhibitor-1 (PAI-1), which is linked with inflammation, pulmonary disease and clotting, can improve outcomes for people with COVID-19. The medicine being used in this study, TM5614, is an investigational drug, which means it is not approved by the U.S. Food and Drug Administration (FDA).
    Shah, Sanjiv JShah, Sanjiv J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04634799 STU00213262
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    Christensen, Lyndsay M.
    TRISCEND II Pivotal
    This study is recruiting patients with Tricuspid Regurgitation (TR), a condition in which the heart’s tricuspid valve does not close tightly which causes the blood to flow in the wrong direction during part of the cardiac cycle (heart beat). This condition increases the workload…
    This study is recruiting patients with Tricuspid Regurgitation (TR), a condition in which the heart’s tricuspid valve does not close tightly which causes the blood to flow in the wrong direction during part of the cardiac cycle (heart beat). This condition increases the workload on the heart and if left untreated, it can increase the risk of worsening heart failure. The goal of this trial is to evaluate the safety and effectiveness of the Study Device with Optimal Medical Therapy (OMT) compared to OMT alone in the study of subjects with severe or greater tricuspid regurgitation.
    Davidson, Charles JDavidson, Charles J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04482062 STU00213338
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    McCloskey, Elizabeth Marie
    iCLAS
    This study is enrolling patients who have an irregular heartbeat(arrhythmia) and have been scheduled for an ablation (procedure that destroys small area of heart tissue that causes an arrhythmia) to treat the arrhythmia. This irregular heart rhythm is also known as atrial fibrillation, or AF. T…
    This study is enrolling patients who have an irregular heartbeat(arrhythmia) and have been scheduled for an ablation (procedure that destroys small area of heart tissue that causes an arrhythmia) to treat the arrhythmia. This irregular heart rhythm is also known as atrial fibrillation, or AF. There are several forms of AF. Persistent AF is when the irregular heart rate become continuous and lasts for at least 7-days but no more than 12 months. Once it has lasted continuously for more than one-year it is referred to as long-standing persistent AF. AF may be treated with medicines, electrical shock(cardioversion), or the ablation for which the patient has been scheduled. The purpose of this study is to demonstrate the safety and effectiveness of the Adagio Medical iCLAS System when used in the treatment of persistent atrial fibrillation. The device is a new type of ablation technology that uses very low freezing temperatures.
    Knight, Bradley PaulKnight, Bradley Paul
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04061603 STU00213038
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    Carswell, Amy Elizabeth
    Polydiuretic in HFpEF
    This study is enrolling patients at Northwestern Memorial Hospital with a history of heart failure with preserved ejection fraction and diabetes mellitus. Doctors at Northwestern University want to better understand if combining three different types of medicines at low doses in…
    This study is enrolling patients at Northwestern Memorial Hospital with a history of heart failure with preserved ejection fraction and diabetes mellitus. Doctors at Northwestern University want to better understand if combining three different types of medicines at low doses into one pill can simplify and improve treatment for people who are prone to retaining fluid because of a condition called heart failure with preserved ejection fraction. Specifically, this is the most common type of heart failure and occurs with a normal ejection fraction or squeezing capacity of the heart muscle. Because patients with diabetes mellitus and heart failure with preserved ejection fraction are more likely to retain fluid, we are studying people with both of these conditions. The medicines being used in this study - bumetanide, eplerenone, and dapagliflozin- are all approved by the Food and Drug Administration (FDA) and commonly prescribed by medical providers for heart failure with preserved ejection fraction (bumetanide and eplerenone) and diabetes mellitus (dapagliflozin). In this study, they will be combined into one pill, a “Low-Dose Triple Polydiuretic Therapy” or “LDTPT” to see if LDTPT leads to reduction in NT-proBNP, a hormone which is high among persons who have heart failure with preserved ejection fraction. The (FDA) has not approved the LDTPT pill for general use and its use in this study is experimental.
    Khan, Sadiya SanaKhan, Sadiya Sana
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04079634 STU00213243
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    HFpEF Diabetes

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    Ramirez, Haydee
    REBALANCE
    This study is enrolling patients diagnosed with a form of heart failure that is characterized by a weakened heart muscle that appears to be pumping in a normal manner. This condition is called “heart failure with preserved ejection fraction” or HFpEF. Patient's heart failu…
    This study is enrolling patients diagnosed with a form of heart failure that is characterized by a weakened heart muscle that appears to be pumping in a normal manner. This condition is called “heart failure with preserved ejection fraction” or HFpEF. Patient's heart failure is not responding well to the medicine that their doctor has prescribed, and they continue to have symptoms. Their doctor has determined that the health problems and symptoms they are experiencing may be due to a significant increase in the pressure of one of the chambers in the heart. This pressure build-up causes a variety of symptoms, including tiredness, difficulty breathing, and reduced ability to exercise/walk. This study will evaluate a new device (the “Axon System”) designed to reduce the build-up of pressure described above. The relief of this pressure may reduce some or all of the symptoms they are experiencing. The Axon System is not yet approved by the US Food and Drug Administration (FDA) and is considered investigational.

    The greater splanchnic nerve (“GSN”) is a nerve that connects to the intestines, liver and spleen. It also communicates with the brain and controls a large volume of the venous blood flow in the body. Researchers believe that in patients with HFpEF the GSN is over-stimulated which causes the body to move more blood into the central veins and lungs. This results in the symptoms experienced, such as shortness of breath with exercise and swelling in the arms or legs. Researchers at Axon decided to study if altering the function of the GSN can improve the symptoms of patients with HFpEF. The purpose of this study is to evaluate the safety and potential benefits of ablation (destruction) of one side of the GSN in patients with HFpEF. Ablation of the GSN is performed for other types of conditions, usually for pain relief in patients with abdominal cancer or chronic pain.

    Patel, Ravi BPatel, Ravi B
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04592445 STU00213774
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    Roshevsky, Daniel Scott
    CATALYST Trial ABT-CIP-10310
    This study is enrolling patients in whom the Amulet device could be beneficial in reducing the risk of ischemic stroke due to non-valvular atrial fibrillation (AF). The purpose of this research study is to compare the safety and effectiveness of the Amulet device compared…
    This study is enrolling patients in whom the Amulet device could be beneficial in reducing the risk of ischemic stroke due to non-valvular atrial fibrillation (AF). The purpose of this research study is to compare the safety and effectiveness of the Amulet device compared to non-vitamin K antagonist oral anticoagulants (NOACs) for ischemic stroke risk reduction. NOACs are a class or type of drugs taken daily, which thin the blood to reduce blood clots and the risk of an ischemic stroke. An ischemic stroke occurs when a small clot prevents blood and oxygen from reaching part of the brain. While NOACs are effective in preventing blood clots and ischemic stroke, thinning of the blood can increase the risk for bleeding events. The Amulet device is intended to be permanently implanted within the LAA. The LAA is a small pouch attached to the upper left chamber of the heart, the left atrium. In patients with non-valvular atrial fibrillation, clots can form in the LAA and travel to the brain, sometimes causing an ischemic stroke. The Amulet device is designed to seal off the LAA from blood flow, preventing clots from leaving the LAA and traveling to the brain. This is accomplished without the need for NOACs or warfarin in most cases.
    Knight, Bradley PaulKnight, Bradley Paul
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04226547 STU00212364
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    Carswell, Amy Elizabeth
    DAPA ACT HF-TIMI 68
    This study is recruiting patients who are hospitalized for acute heart failure. This study will test whether the drug dapagliflozin is safe and has beneficial effects when added to conventional heart failure therapy in patients who have been admitted to the hospital for acute hear…
    This study is recruiting patients who are hospitalized for acute heart failure. This study will test whether the drug dapagliflozin is safe and has beneficial effects when added to conventional heart failure therapy in patients who have been admitted to the hospital for acute heart failure and whose heart is not pumping enough blood with each heartbeat.
    Tibrewala, AnjanTibrewala, Anjan
    • Map it 300 Randall Road
      Geneva, IL
    NCT04363697 STU00213500
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    Petersen, Julie A
    MYK-461-019 EMBARK
    This study is recruiting patients who have been diagnosed with Heart Failure with Preserved Ejection Fraction. The study will test whether a drug called mavacamten can lower blood levels of cardiac troponin (a marker of heart muscle injury) and/or NT-proBNP (a marker of heart wall …
    This study is recruiting patients who have been diagnosed with Heart Failure with Preserved Ejection Fraction. The study will test whether a drug called mavacamten can lower blood levels of cardiac troponin (a marker of heart muscle injury) and/or NT-proBNP (a marker of heart wall stress). These “biomarkers” are increased in the blood of some people with HFpEF. Additionally, the main research study will provide preliminary information regarding tolerability and safety of mavacamten treatment in HFpEF. Mavacamten is an investigational drug. This means that it has not been approved by the Food and Drug Administration (FDA) or any regulatory agency for routine clinical use, including the treatment of HFpEF.
    Patel, Ravi BPatel, Ravi B
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04766892 STU00213899
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    Ramirez, Haydee
    HM3 SWIFT
    This study is enrolling patients who are scheduled to receive the HeartMate 3 Left Ventricular Assist Device as part of their standard medical care to treat their heart failure and help their heart pump blood. The purpose of this study is to collect medical information and experiences with …
    This study is enrolling patients who are scheduled to receive the HeartMate 3 Left Ventricular Assist Device as part of their standard medical care to treat their heart failure and help their heart pump blood. The purpose of this study is to collect medical information and experiences with the HeartMate 3. The conventional method to implant the HeartMate 3 is an incision in the middle of the chest through the breastbone (also called the sternum). This study will collect data in patients who have the pump implanted using an incision on their left side and another incision in their upper right chest.
    Pham, Duc ThinhPham, Duc Thinh
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04548128 STU00213418
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    HM3 HeartMate LVAD

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    Reinkensmeyer, Alexandra Laure
    The RPM Study
    This study is recruiting patients who are scheduled for a heart procedure or are currently in the hospital for a heart related condition or procedure. The purpose of this study is to collect data from small biosensors placed on different parts of your body. The term “biosensor” is s…
    This study is recruiting patients who are scheduled for a heart procedure or are currently in the hospital for a heart related condition or procedure. The purpose of this study is to collect data from small biosensors placed on different parts of your body. The term “biosensor” is short for “biological sensor”. The sensors used in this study are about the size of a Band-Aid. Biosensors are placed directly on the skin and do not pierce the skin, however they can be used to detect changes in your body, such as skin temperature, heart rate and rhythm, blood pressure, glucose (blood sugar), sweat, electrolytes (minerals in the body fluids) and breathing rate. Additionally, biosensors can track body movements and capture sound vibrations, The data collected by these sensors will be compared to the typical measurements that are routinely collected when you are in the hospital. This will allow us is to see if the data from these biosensors is as accurate as the current ways this information is collected. The sensors measures continuously and several of the devices used in this study transfer data wirelessly to a computer, smart phone or tablet. Collecting these different measurements wirelessly may be a way for physicians to understand how well the body and organs are functioning without the need to attach bulky devices with wires.
    Pandit, Jay APandit, Jay A
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00213919
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    Roshevsky, Daniel Scott
    Champion-AF
    This study is recruiting patients who have a heart condition in which the upper chambers of your heart beat irregularly. This condition, also known as atrial fibrillation (AF), can cause blood clots to form in an area of your heart call the left atrial appendage (LAA). Everyone has a LAA,…
    This study is recruiting patients who have a heart condition in which the upper chambers of your heart beat irregularly. This condition, also known as atrial fibrillation (AF), can cause blood clots to form in an area of your heart call the left atrial appendage (LAA). Everyone has a LAA, which is like a pouch on the top of your heart, and it developed along with other parts of the heart before birth. If a clot forms here, it can increase your chances of having a stroke or other related problems. There are two currently recognized standard of care treatments to prevent stroke in patients with atrial fibrillation. The first is long-term oral anticoagulation (OAC)therapy (blood thinner medication). The second is the implant of a WATCHMAN FLXTM Device (the “Device”),which is permanently implanted in the LAA of your heart to close it off from the rest of the heart, followed by short-term OAC therapy. The WATCHMAN FLXTM Device operate on the principle that if the LAA is closed, the blood clots might not be able to form in that area. The purpose of this study is to evaluate the safety and effectiveness of the WATCHMAN FLX TM (the “Device”) Device compared to treatment with non-vitamin K antagonist oral anticoagulation, also known as NOACs (“Control”) therapy to determine if it works for patients with your type of atrial fibrillation who require treatment for potential blood clot formation (thrombus) in the LAA. The device will be permanently implanted in the LAA of your heart to close it off.
    Lin, Albert Chao-tunLin, Albert Chao-tun
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04394546 STU00213843
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    Carswell, Amy Elizabeth
    PULSED AF
    This study is recruiting patients who have been diagnosed with atrial fibrillation, also known as “AF or “Afib”. AF is an irregular heartbeat (arrhythmia), often with a very fast heart rate. AF is known as either paroxysmal AF (symptoms stop on their own within 7 days) or persistent A…
    This study is recruiting patients who have been diagnosed with atrial fibrillation, also known as “AF or “Afib”. AF is an irregular heartbeat (arrhythmia), often with a very fast heart rate. AF is known as either paroxysmal AF (symptoms stop on their own within 7 days) or persistent AF (symptoms last longer than 7 days and the heart’s rhythm can’t regulate itself anymore). The study is recruiting patients whose doctor recommend that they have a cardiac ablation procedure to treat their AF. Patients will be treated with the PulseSelect Pulsed Field Ablation(PFA) system. The purpose of this study is to provide data demonstrating the safety and effectiveness of the PFA system for the treatment of AF. The study will also provide first in human insights into clinical safety and device function of the PFA system for pulmonary vein isolation (a type of cardiac ablation procedure which focuses on treatment where the four pulmonary veins connect to the heart) as a treatment for AF.
    Knight, Bradley PaulKnight, Bradley Paul
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04198701 STU00214407
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    Carswell, Amy Elizabeth
    FLASH Registry
    This study is recruiting patients whose doctor may use or has used FlowTriever to treat their pulmonary embolism (PE), or whose doctor may prescribe or has prescribed anticoagulation medication (blood thinners) to treat their PE. The purpose of the study is to collect information about…
    This study is recruiting patients whose doctor may use or has used FlowTriever to treat their pulmonary embolism (PE), or whose doctor may prescribe or has prescribed anticoagulation medication (blood thinners) to treat their PE. The purpose of the study is to collect information about how the FlowTriever works when treating PE, how anticoagulation medications works when treating PE, and also to collect data about PE treatment. The FlowTriever Retrieval/Aspiration System (referred to as “FlowTriever”) is an FDA cleared device designed to treat pulmonary embolism (PE) in the lung by removing blood clots from blood vessels. A PE is a blood clot trapped in the lung. The FlowTriever is used to trap the clot and pull it into a catheter so that the clot can be removed from the body. The study will also look at how anticoagulation medication works when treating PE. Anticoagulation medication prevents clots from forming in blood vessels. This research study is a registry. Registries are real-world databases that can be used to track how patients respond to particular medical devices. This registry will help us learn things to help future patients.
    Schimmel, Daniel RichardSchimmel, Daniel Richard
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00214260
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    Canino, Courtney Victoria