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
BEST-CLI
The BEST-CLI study This study is recruiting participants diagnosed with peripheral artery disease (PAD) that has led to critical limb ischemia (CLI). In CLI, arteries that deliver blood to the leg and foot are narrowed or blocked by plaque buildup (atherosclerosis). CLI can cause pain in the…
The BEST-CLI study This study is recruiting participants diagnosed with peripheral artery disease (PAD) that has led to critical limb ischemia (CLI). In CLI, arteries that deliver blood to the leg and foot are narrowed or blocked by plaque buildup (atherosclerosis). CLI can cause pain in the foot or leg even when sitting or lying at rest; it also can cause foot and leg ulcerations, and can sometimes lead to gangrene and loss of the leg. CLI is usually treated by operations or procedures that increase blood flow to the leg and foot, in order to relieve these symptoms, heal the ulcers, and preserve the limb. There are two different ways to increase the blood flow in CLI. One is with open surgery, which creates a bypass around the blockage. The other is with endovascular treatment (often called angioplasty), a minimally invasive procedure that opens the blocked arteries directly. Angioplasty is performed with balloons and other tools that clear plaque, and sometimes permanent implantation of small, mesh-like metal tubes called “stents”. Both types of treatment – open surgery and angioplasty - are considered reasonable and appropriate for patients with CLI. Half of the participants in this study will have open surgery and half will have endovascular treatment. The assignment of treatment is random, meaning purely by chance (50:50, just like a coin toss). The purpose of the study is to learn about which therapy is more suitable for those patients who are candidates for both open surgery and endovascular treatment, and to provide information regarding cost effectiveness of the two different types of treatment. We expect 2100 participants to enroll from approximately 120 different study centers across the United States, Canada, and possibly other countries. We hope to enroll up to 20 participants at Northwestern.
Eskandari, MarkEskandari, Mark
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02060630 STU00101601
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Reinkensmeyer, Alexandra
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
A Prospective Study of Breast Cancer patients with Abnormal Strain Imaging
This study will help us to determine if prophylactic beta-blocker therapy, in patients with preclinical changes in LV function, will prevent a worsening of strain, allowing patients to stay on their chemotherapy treatment.

Main Inclusion:

  • Patients > 18 years of age with HER2-overexpressing early stage breast cancer (Stages I – III)
  • Pathology report must include HER2 expression, estrogen and progesterone receptor status
  • Normal LV function (EF > 53%) on baseline echocardiogram
  • NYHA functional class I-II
  • Scheduled to receive treatment with anthracycline and/or trastuzumab and pertuzumab-based regimens

Main Exclusion:

  • Pre-existing cardiac disease (moderate-severe coronary artery disease, moderate-severe valvular heart disease, constrictive/restrictive cardiomyopathies)
  • Metastatic breast cancer
  • Prior use of BB/ACE therapy
  • 2nd and 3rd degree AV block, Sick Sinus Syndrome, severe bradycardia (<50 BPM), or severe hypotension (SBP < 85 mmHg)
  • Severe liver dysfunction or moderate-severe asthma
Akhter, NausheenAkhter, Nausheen
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02993198 STU00200675
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Ramirez, Haydee
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, AlbertLin, Albert
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02513797 STU00201623
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Carswell, Amy
KNO3CK OUT HFPEF
KNO3CK-OUT HFpEF: This study is enrolling participants with a diagnosis of heart failure with preserved ejection fraction (HFpEF). This is a condition that causes patients to be short of breath and limited in what they can do in their daily lives. Currently, there are no approved dru…
KNO3CK-OUT HFpEF: This study is enrolling participants with a diagnosis of heart failure with preserved ejection fraction (HFpEF). This is a condition that causes patients to be short of breath and limited in what they can do in their daily lives. Currently, there are no approved drugs for this condition. Researchers are trying to find new therapies for this condition. The purpose of this study is to test whether Potassium Nitrate (KNO3) will improve how people with HFpEF can exercise. In HFpEF, patients are limited in their ability to do all the things they want to do, and exercise as much as they would like, due to becoming tired and short of breath early. We do not know exactly why these limitations occur. There is some evidence that in addition to problems with the heart, patients with HFpEF also have problems with their arteries and muscles that affect their ability to exercise. Potassium Nitrate has been shown to improve how muscles work and also improve blood flow to working muscles in the body in healthy individuals. We previously conducted a pilot study with our KNO3 pills and found them to be safe in subjects with HFpEF. We would like to now study our pills in a large study to see if we can improve exercise in HFpEF. The use of Potassium Nitrate in this study is investigational. Potassium Nitrate has not been approved by the Food and Drug Administration (FDA) for the use being evaluated in this study.
Shah, Sanjiv JShah, Sanjiv J
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02840799 STU00202379
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Dvorak, Stephen
PARTNER 3
This research study will evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) Model 9600TFX and associated delivery systems in patients with symptomatic, severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replace…
This research study will evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) Model 9600TFX and associated delivery systems in patients with symptomatic, severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement (AVR). Low operative risk means that patients may have less than a 2% chance of death 30 days after open-heart surgery. The delivery system is the Commander system, which uses transfemoral access (through a blood vessel in the leg) to place the valve in the heart. Patients agreeing to participate in this investigational (experimental) study will have a 50/50 chance of receiving the study device or surgical aortic valve replacement (SAVR). Participation in this research study 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 no more than 120 people will be enrolled at Northwestern The study expects to enroll up to 1228 people at up to 50 sites nationally
Malaisrie, S Chris ChrisMalaisrie, S Chris Chris
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02675114 STU00202604
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Warzecha, Anna
ADAPTABLE
Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE). The goal of ADAPTABLE is to try to find out which dose of aspirin is better for subjects who have heart disease. Subjects who join this study will take either low-dose or regular aspirin ever…
Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE). The goal of ADAPTABLE is to try to find out which dose of aspirin is better for subjects who have heart disease. Subjects who join this study will take either low-dose or regular aspirin every day. That way, we can learn which is better in terms of reducing the risk of heart attacks, strokes, bleeding, and death. We expect up to 15,000 subjects with heart disease from across the U.S. will take part in ADAPTABLE.
Criteria


Inclusion Criteria:
• Known atherosclerotic cardiovascular disease (ASCVD), defined by a history of prior myocardial infarction, prior coronary angiography showing ≥75% stenosis of at least one epicardial coronary vessel, or prior coronary revascularization procedures (either PCI or CABG), or history of chronic heart disease, CAD, ASCVD
• Age ≥ 18 years
• No known safety concerns or side effects considered to be related to aspirin, including
• No history of significant allergy to aspirin such as anaphylaxis, urticaria, or significant gastrointestinal intolerances
• No history of significant GI bleed within the past 12 months
• Significant bleeding disorders that preclude the use of aspirin
• Access to the Internet. In the event that the CDRNs are notified that a cohort of patients without internet access can be included, then patient agreement will be obtained during the consent process to provide follow-up information by telephone contact with the DCRI Call Center.
• Not currently treated with an oral anticoagulant - either warfarin or a novel anticoagulant (dabigatran, rivaroxaban, apixaban, edoxaban) - and not planned to be treated in the future with an oral anticoagulant for existing indications such as atrial fibrillation, deep venous thrombosis, or pulmonary embolism.
• Not currently treated with ticagrelor and not planned to be treated in the future with ticagrelor.
• Female patients who are not pregnant or nursing an infant
• Estimated risk of a major cardiovascular event (MACE) > 8% over next 3 years as defined by the presence of at least one or more of the following enrichment factors:
• Age > 65 years
• Serum creatinine > 1.5 mg/dL
• Diabetes mellitus (Type 1 or Type 2)
• 3-vessel coronary artery disease
• Cerebrovascular disease and/or peripheral arterial disease
• Left ventricular ejection fraction (LVEF) < 50%
• Current cigarette smoker
• Chronic systolic or diastolic heart failure
• SBP > 140 (within past 12 mos)
• LDL > 130 (within past 12 mos)

Exclusion Criteria:
• There will be no exclusions for any upper age limit, comorbid conditions, or concomitant medications other than oral anticoagulants and ticagrelor that are used at the time of randomization, or are planned to be used during the study follow-up.
• Patients and sites interested in participating must be part of the listed health systems collaborators.
Kho, Abel NKho, Abel N
  • Map it 675 N. St. Clair St.
    Chicago, IL
NCT02697916 STU00203465
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Nodal, Mercedes
EVOQUE
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…
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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Brady, Caitlin
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, AndrewHoel, Andrew
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02777593 STU00203850
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Reinkensmeyer, Alexandra
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 Chris ChrisMalaisrie, S Chris Chris
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03033043 STU00204570
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Brady, Caitlin
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 Chris ChrisMalaisrie, S Chris Chris
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03003299 STU00204739
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Kats, Lauren
PRESERVED-HF
This study is recruiting people who have Type 2 diabetes mellitus (T2DM) or prediabetes and heart failure (Inability of the heart to pump blood with normal efficiency). The purpose of the study is to find out if a drug called dapagliflozin would be effective in improving the blood tes…
This study is recruiting people who have Type 2 diabetes mellitus (T2DM) or prediabetes and heart failure (Inability of the heart to pump blood with normal efficiency). The purpose of the study is to find out if a drug called dapagliflozin would be effective in improving the blood tests and symptoms related to heart failure while also treating type 2 diabetes or potentially preventing type 2 diabetes if you have pre-diabetes. To do this, dapagliflozin will be compared with placebo. The placebo will look like dapagliflozin but is inactive. Dapagliflozin lowers glucose (sugar) levels in the blood by blocking the effect of specific molecules (small particles) called sodium-glucose transporters. Under normal circumstances, the sodium-glucose transporters in the kidney prevent glucose in the blood stream from leaving the body through urine. Dapagliflozin inhibits the sodium-glucose transporters and lowers blood glucose by allowing glucose removal through the urine. Dapagliflozin may also mildly decrease body weight and lower blood pressure in certain patients. Dapagliflozin is approved by the United States Food and Drug Administration (FDA) for the treatment of type 2 diabetes. Dapagliflozin is not specifically approved for the treatment of type 2 diabetes in people with heart failure and therefore its use in this study is investigational. We expect up to 20 people here will be in this research study out of 320 people in the entire study nationally..

  • Age > 18 and < 120 at the screening visit 
  • Symptoms of dyspnea (NYHA class II-IV) without evidence of a non-cardiac or ischemic explanation for dyspnea 
  • Ejection fraction (EF) ≥ 45% as determined on imaging study within 24 months of enrolment with no change in clinical status suggesting potential for deterioration in systolic function 
  • Elevated NT-proBNP (≥ 225 pg/ml) or BNP (≥ 75 pg/ml)
  • Stable medical therapy for heart failure for 15 days as defined by: i. No addition or removal of ACE, angiotensin receptor blockers (ARBs), valsartan/sacubitril, beta-blockers, calcium channel blockers (CCBs) or aldosterone antagonists ii. No substantial change in dosage (100% or greater increase or decrease from baseline dose) of ACE, ARBs, beta-blockers, CCBs or aldosterone antagonists 
  • On a diuretic ≥15 days prior to screening visit and a stable diuretic therapy for 7 days

Khan, SadiyaKhan, Sadiya
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03030235 STU00204842
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Roshevsky, Daniel Scott
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
REDUCE II
The purpose of this study is to evaluate the safety and effectiveness of an investigational device for heart failure symptoms. Investigational means it has not been approved by the USA Food and Drug Administration (FDA).The device is called the IASD System II, which is an “inter-atrial sh…
The purpose of this study is to evaluate the safety and effectiveness of an investigational device for heart failure symptoms. Investigational means it has not been approved by the USA Food and Drug Administration (FDA).The device is called the IASD System II, which is an “inter-atrial shunt”. The device is permanently implanted into the heart. It is designed to reduce the pressure in a part of the heart called the left atrium. This is done by creating a small opening between the left atrium and the right atrium of your heart. If it lowers the pressure in your heart at rest or during activity, it may lessen some of the symptoms you have. You have a 50% chance of receiving the device and a 50% chance of being in the control group for 2 years and then you may have the option of receiving the device This study is an FDA approved clinical trial for this device. The FDA will review the safety results and the treatment effect found in this study. If the FDA accepts the research results the FDA can approve the device for sale in the USA. In April 2016, the Study Device received CE Marking, which is an approval that allows it to be sold in the European Union. If you agree to participate in this study, we expect that you will be involved for about five (5) years. Being in this study requires regular doctor visits. There are visits for testing before the procedure. After the procedure, there are visits at 1 month, 3 months, 6 months and 12 months, and then yearly visits until 5 years after the procedure. The study is over when all the subjects have had their last doctor visit. We expect up to 12 people here will be in this research study out of 700 people in the entire study internationally
INCLUSION CRITERIA: 

  • Chronic symptomatic heart failure (HF) documented by the following: 
    • Symptoms of HF requiring current treatment with diuretics for ≥ 30 days 
    • New York Heart Association (NYHA) class II with a prior history of > NYHA class II; NYHA class III, or ambulatory NYHA class IV symptoms (paroxysmal nocturnal dyspnea, orthopnea, dyspnea on mild or moderate exertion) at screening visit; or signs (any rales post cough, chest x-ray demonstrating pulmonary congestion,) within past 12 months; AND 
    • ≥ 1 HF hospital admission (with HF as the primary, or secondary diagnosis); or treatment with intravenous (IV), or intensification of oral diuresis for HF in a healthcare facility (emergency department/acute care facility), within the 12 months prior to study entry; OR an NT-pro BNP value > 150 pg./ml in normal sinus rhythm, > 450 pg./ml in atrial fibrillation, or a BNP value > 50 pg./ml in normal sinus rhythm, > 150 pg./ml in atrial fibrillation within the past 6 months. 
  • 2.Ongoing stable GDMT HF management and management of potential comorbidities according to the 2013 ACCF/AHA Guidelines for the management of Heart Failure, with no significant changes (>100% increase or 50% decrease), excluding diuretic dose changes, for a minimum of 4 weeks prior to screening which is expected to be maintained for 6 months. 
  • 3.Age ≥ 40 years old 
  • 4.Site determined echocardiographic LV ejection fraction ≥40% within the past 6 months,without documented ejection fraction <30% in the 5 years prior to study entry. 
EXCLUSION CRITERIA 

  • MI and/or percutaneous cardiac intervention within past 3 months; CABG in past 3 months, or current indication for coronary revascularization; AVR (surgical AVR or TAVR) within the past 12 months. 
  • Cardiac resynchronization therapy initiated within the past 6 months 
  • Advanced heart failure defined as one or more of the below: 
    • a.ACC/AHA/ESC Stage D heart failure, Non-ambulatory NYHA Class IV HF; 
    • b.Cardiac index < 2.0 L/min/m2 
    • c.Inotropic infusion (continuous or intermittent) for EF < 40% within the past 6 months 
    • d.Patient is on the cardiac transplant waiting list4.Inability to perform 6 minute walk test (distance < 50 m), OR 6 minute walk test > 600m 
  • 5.The patient has verified that the ability to walk 6 minutes is limited primarily by joint, foot, leg, hip or back pain; unsteadiness or dizziness or lifestyle and not by shortness of breath and/or fatigue and/or chest pain. 

Ricciardi, MarkRicciardi, Mark
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03088033 STU00204899
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Roshevsky, Daniel Scott
AAA Geometric Surrogates
An Abdominal Aortic Aneurysm (AAA) is a balloon-like expansion of the aorta, the large artery that transports blood from the heart to the rest of the body, in the abdominal area just below the kidneys. As part of routine monitoring care for patients diagnosed with AAA, at lea…
An Abdominal Aortic Aneurysm (AAA) is a balloon-like expansion of the aorta, the large artery that transports blood from the heart to the rest of the body, in the abdominal area just below the kidneys. As part of routine monitoring care for patients diagnosed with AAA, at least semi-annual evaluations are performed using imaging methods such as a computed tomography (CT) scan. Magnetic Resonance Imaging (MRI) is another method of creating pictures of the same vessels seen on a CT scan. MRI is a method for producing extremely detailed pictures of blood vessels without the need for x-rays. Radio waves, along with the magnetic field of a large magnet within the MRI machine, are used to make the pictures. MR images are used to detect and aid in the diagnosis of heart disorders and blood vessel diseases. For the purpose of this research, along with the routine CT scan, an additional scan called a ECG-gated MRI exam will be performed. This MRI exam does not involve any contrast, a dye used to make tissues, abnormalities or diseases processes more visible. This one-time MRI exam will be performed prior to anticipated elective AAA repair or during the course of periodic surveillance for AAA. This research study plans to enroll approximately 200 study participants at approximately 3 sites, including approximately 100 people at Northwestern.
Participants may be eligible for this study if they have been diagnosed with an Abdominal Aortic Aneurysm and either have been recommended to undergo elective repair or are currently under periodic surveillance for AAA.
Eskandari, MarkEskandari, Mark
  • Map it 201 E. Huron St.
    Chicago, IL
STU00205143
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Reinkensmeyer, Alexandra
ASAP-TOO
This study will evaluate the safety and effectiveness of the WATCHMAN Device in patients who cannot use oral anticoagulation (OAC) therapy (blood thinner medication). Participants in this study will be assigned by chance (“randomized”) to one of two groups: the Device Group or the Contro…
This study will evaluate the safety and effectiveness of the WATCHMAN Device in patients who cannot use oral anticoagulation (OAC) therapy (blood thinner medication). Participants in this study will be assigned by chance (“randomized”) to one of two groups: the Device Group or the Control Group. There will be two people assigned to the Device Group for every one person assigned to the Control Group. Participants in the Device Group will be scheduled for WATCHMAN Device implantation. Participants the Control Group will not have the device implanted and will be prescribed single antiplatelet therapy or no therapy for the duration of the trial at the discretion of the study physician. In this study, the WATCHMAN Device itself and the implantation procedure are the same as the FDA approved WATCHMAN. The only difference is that no OAC therapy will be administered after implant. Therefore, the use of the WATCHMAN Device in this study is considered “investigational” because it has not been approved by the FDA for use without short-term OAC therapy. Participants in this study will be in this research study for about 5 years. During this time, participants will be asked to come to clinic for 6-7 study visits, and the study team will contact participants by telephone for 5 phone “visits”. We expect up to 70 people here will be in this research study out of 888 people in the entire study internationally.
Inclusion Criteria:
Documented paroxysmal, persistent, permanent or long-term/longstanding persistent non-valvular atrial fibrillation. The subject has a calculated CHA2DS2-VASc score of 2 or greater.
Deemed by two study physicians to be unsuitable for oral anticoagulation.
Deemed by a study physician to be suitable for the defined protocol pharmacologic regimen of aspirin and clopidogrel therapy following WATCHMAN Closure Device implant.
Able and willing to return for required follow-up visits and examinations.

Exclusion Criteria:
The subject had or is planning to have any invasive cardiac procedure within 30 days prior to randomization (e.g., cardioversion, ablation).
Planning to have any cardiac or non-cardiac invasive or surgical procedure that would necessitate stopping or modifying the protocol required medication regimen within 90 days after the WATCHMAN Closure Device implant (e.g., cardioversion, ablation, cataract surgery).
Prior stroke (of any cause) or TIA within the 30 days prior to randomization.
Prior bleeding event within the 14 days prior to randomization.
History of atrial septal repair or has an ASD/PFO device.
An implanted mechanical valve prosthesis in any position.
The subject suffers from New York Heart Association Class IV Congestive Heart Failure.
The subject has LVEF < 30%.
Knight, Bradley PaulKnight, Bradley Paul
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02928497 STU00205007
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Carswell, Amy
INVESTED
Influenza infection (“the flu”) is known to be associated with a higher risk for heart problems. The purpose of this study is to see if an investigational high-dose influenza (“flu”) vaccine is able to safely reduce heart or lung-related problems compared to the standard-dose flu vac…
Influenza infection (“the flu”) is known to be associated with a higher risk for heart problems. The purpose of this study is to see if an investigational high-dose influenza (“flu”) vaccine is able to safely reduce heart or lung-related problems compared to the standard-dose flu vaccine. Both the high dose and standard dose flu vaccines called Fluzone® are being provided for use in the study by Sanofi Pasteur, which manufactures the vaccines. The standard dose vaccine is approved by the Food and Drug Administration (FDA) for protecting against influenza disease caused by influenza A and influenza B viruses.  The high dose vaccine is approved by the FDA for the same reason, but only for adults who are at least65 years old. Thus its use with adults younger than 65 in this study is investigational.
This study is recruiting patients who have had a heart attack or have heart failure.
Mutharasan, R KannanMutharasan, R Kannan
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02787044 STU00205380
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Ramirez, Haydee
ACTIVE: Edwards Cardioband System Pivotal Clinical Trial
This study is enrolling patients with moderate-to-severe or severe functional mitral regurgitation (FMR). FMR occurs when the two leaflets of the mitral valve do not close properly, causing blood to leak backward with each heartbeat. Since so…
This study is enrolling patients with moderate-to-severe or severe functional mitral regurgitation (FMR). FMR occurs when the two 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 has to pump more blood with each beat to push the same amount of blood forward. This can lead to shortness of breath and make the heart weaker because it cannot pump enough blood for the body’s needs. The purpose of this study is to evaluate a new device to treat patients who might benefit from repair of their mitral heart valve due to functional mitral regurgitation. The device is called the Edwards Cardioband System (“Edwards Cardioband System”). The device is investigational, which means it is not yet approved by the U.S. FDA for sale in the United States. This device is placed without the need for an open-heart procedure and without the need for a heart and lung machine. Instead, the device is delivered using a less invasive approach where the Cardioband System is inserted through a vein in the groin and threaded to the heart using a delivery catheter (small plastic tube). For this study patients will be “randomized” or assigned by chance to one of two study groups: Device group or the Control group. Patients will be randomized 2:1, which means each patient has a 2 to 1 chance of being assigned to the Device group (twice as likely to be in the Device group as the Control group). Subjects assigned to the Control Group may be eligible to receive the Study Device after their 1 year study visit. Participation in this study will last for approximately 5 years. Both Device and Control Group participants will be asked to return for visits at 1 month, 6 months, and 1, 2, 3, 4 and 5 years. This study is being conducted in up to fifty (50) hospitals in the United States, Canada, and/or Europe and plans to enroll up to 525 participants, including approximately 10 people from this institution
Inclusion: 

  • Functional MR (≥3+ by echo) 
  • Patient hospitalized due to heart failure during 12 months prior to enrollment OR BNP >400 pg/ml or NT‐BNP >1500 pg/ml 
  • LVEF >20% and LVEDD ≤70mm 
  • NYHA Class II‐IVa heart failure symptoms despite medical therapy 
Exclusion: 

  • Degenerative MR including mixed degenerative/functional MR
  • Severe mitral annular calcification
  • Hypertrophic cardiomyopathy
  • Severe tricuspid regurgitation

Davidson, Charles JDavidson, Charles J
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03016975 STU00205575
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Brady, Caitlin
SERENADE
The purpose of this study is to find out whether a drug called “macitentan” works and is safe in patients with Heart Failure with Preserved Ejection Fraction and Pulmonary Vascular Disease. There are several drugs available to manage heart failure symptoms, but to date, no treatments ha…
The purpose of this study is to find out whether a drug called “macitentan” works and is safe in patients with Heart Failure with Preserved Ejection Fraction and Pulmonary Vascular Disease. There are several drugs available to manage heart failure symptoms, but to date, no treatments have been approved specifically for left heart failure with preserved ejection fraction and pulmonary vascular disease. Macitentan may reduce unwanted effects of a chemical substance in the body called endothelin, which has been detected in increased amounts in patients with heart failure. Endothelin causes blood vessels to narrow and results in overgrowth of the muscle in the walls of the lung blood vessels and also of the heart. By blocking the action of endothelin, macitentan lowers the blood pressure in the pulmonary arteries, may slow down overgrowth of the heart muscle and may therefore improve your condition. Macitentan has been tested and approved in the U.S. for other diseases, but is considered experimental for the use in this study. We expect participants will be in this research study for 70 weeks, and will need to come to clinic for study visits 13 times. We expect up to 5 people here will be in this research study out of 300 people in the entire study internationally.

Primary Inclusion:

  • Signs or symptoms of Heart Failure (HF) requiring treatment with at least one oral diuretic (any type). 
  • Left ventricular ejection fraction (LVEF) ≥ 40% 
  • Structural heart disease consistent with heart failure with preserved ejection fraction (HFpEF). 
  • HF hospitalization within 12 months prior to Screening and/or cardiac catheterization performed within 6 months prior to Screening.  
  • Pulmonary vascular disease or right ventricular dysfunction

Primary Exclusion: 

  • Any prior measurement of LVEF < 40%. 
  • Cardiovascular co-morbidities (e.g., significant unrepaired structural valvular heart disease; acute coronary syndrome, coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) within 3 months of Screening; uncontrolled heart rate from atrial fibrillation or atrial flutter, history of serious life-threatening or hemodynamically significant arrhythmia) 
  • Hemoglobin < 100g/L (< 10 g/dl) 

Freed, BenjaminFreed, Benjamin
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03153111 STU00205418
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Sanchez, Cynthia
REVAMP
REVAMP: The purpose of this study is to see if pacing the right atrium of the heart at a higher rate for periods of time can help the left ventricle (LV) pump blood better, and if it improves exercise capacity and quality of life for patients who have HFpEF, normal to small LV chambers, and ev…
REVAMP: The purpose of this study is to see if pacing the right atrium of the heart at a higher rate for periods of time can help the left ventricle (LV) pump blood better, and if it improves exercise capacity and quality of life for patients who have HFpEF, normal to small LV chambers, and evidence of thickened walls. This study will be conducted with patients who have a market-released Medtronic dual chamber pacemaker with a Sleep Function, and have had this pacemaker for at least 6 months. Any Medtronic dual chamber pacemaker with the Sleep Function will qualify.In patients with HFpEF, the chamber of the heart that pumps blood out to the body tends to be stiff with thickened walls, reducing the amount of blood that can be pumped with each heartbeat. Previous research suggests that raising the heart rate may reduce the thickness of the heart chamber walls and increase the amount of blood pumped with each heartbeat.This research study plans to enroll approximately 40 study participants at approximately 5 sites, including approximately 15 people from this institution.

  • Subject has had a market released dual chamber Medtronic Pacemaker with a Sleep function for at least 6 months 
  • Subject is stable on current medications 
  • Subject has dyspnea with exertion
  • Subject has had a prior Echo in past 6 months with: EF ≥ 50% and Diastolic volume <80 ml/m2 
  • Subject has evidence of hypertrophy (indexed to body surface area: men 115 g/m2, women 95 g/m2 or indexed to height: men 49.2 g/m2.7 , women 46.7 g/m2.7 ) or Relative Wall thickness >0.42, or Wall Thickness>1.2cm (posterior wall)

Shah, Sanjiv JShah, Sanjiv J
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03210402 STU00205515
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Reinkensmeyer, Larissa
BAY16 REALIsM
The study aims to explore two marketed devices, monitoring physical activity under real-life conditions in patients with HFpEF and HFrEF. Furthermore, it aims to address the challenges and feasibility of implementing device based measurements under real-life condition…

The study aims to explore two marketed devices, monitoring physical activity under real-life conditions in patients with HFpEF and HFrEF. 

Furthermore, it aims to address the challenges and feasibility of implementing device based measurements under real-life conditions.

Female and male subjects with a diagnosis of acute decompensated heart failure with preserved ejection fraction (HFpEF; EF ≥ 45%) or

acute decompensated heart failure with reduced ejection fraction (HFrEF; EF ≤ 35%) will be enrolled.

Shah, Sanjiv JShah, Sanjiv J
  • Map it 201 E. Huron St.
    Chicago, IL
STU00206315
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Ramirez, Haydee
APOLLO TMVR
This study is enrolling subjects with 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 purpos…
This study is enrolling subjects with 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.
INCLUSION: 1) Subject has severe symptomatic mitral regurgitation as defined by the ASE. 2) Patient is a candidate for bioprosthetic mitral valve replacement EXCLUSION: 1) Prior mitral valve surgery including previously implanted mitral valve, ring, or band. 2) Heart Team agrees predicted risk of operative mortality is
McCarthy, Patrick MMcCarthy, Patrick M
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03242642 STU00206197
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Christensen, Lyndsay
LMNA Cardiomyopathy
This study is enrolling patients diagnosed with LMNA-related dilated cardiomyopathy (DCM), who have an irregular heart rhythm (arrhythmia) or their heart is not working properly (myocardial dysfunction). For this study, we are evaluating use of a medication, colchicine, to see if …
This study is enrolling patients diagnosed with LMNA-related dilated cardiomyopathy (DCM), who have an irregular heart rhythm (arrhythmia) or their heart is not working properly (myocardial dysfunction). For this study, we are evaluating use of a medication, colchicine, to see if it can help improve heart function and reduce irregular heart rhythms in patients with LMNA related DCM
1. Confirmed diagnoses of LMNA cardiomyopathy (confirmed with genetic testing). 2. Evidence of myocardial dysfunction OR cardiac arrhythmia
Wilcox, Jane ElizabethWilcox, Jane Elizabeth
  • Map it 201 E. Huron St.
    Chicago, IL
STU00206184
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Roshevsky, Daniel Scott
CAPACITY HFpEF

A Study Evaluating the Safety and Efficacy of Different Doses of IW-1973 over 12 Weeks in Patients with Heart Failure with Preserved Ejection Fraction.

  • Patients with heart failure with ejection fraction (EF) of ≥40% as assessed within 12 months of the Screening Visit
  • Ability to complete a cardiopulmonary treadmill exercise test
  • Patient meets at least 2 of the following criteria at the Screening Visit:
    • Diagnosis of type 2 diabetes mellitus or prediabetes (currently treated or hemoglobin A1c ≥5.6)
    • History of hypertension (on at least 1 antihypertensive medication or has current seated blood pressure [BP] >140/90 mmHg)
    • Body mass index (BMI) >30 kg/m2
    • Age ≥70 years
Freed, BenjaminFreed, Benjamin
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03254485 STU00206096
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Reinkensmeyer, Larissa
P3 MITRAL Valve in Valve
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 failing valve. Each valve consists of a stent (mesh tube made of metal) to hold the study device in…

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 failing 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 your heart. 

We expect that participation in this study will last approximately 10 years. Participants will have the study device implanted, and will need to come to clinic for 13 planned study visits.

This study will enroll patients with symptomatic heart disease due to a failing bioprosthetic mitral valve (stenosed, insufficient, or combined)
Malaisrie, S Chris ChrisMalaisrie, S Chris Chris
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03193801 STU00205381
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Kats, Lauren
CIRB - Dilated Cardiomyopathy (DCM) Research Project
Dilated cardiomyopathy (DCM) is a condition in which the heart becomes enlarged and the heart muscle weakened, causing the heart to pump blood less efficiently. DCM is commonly caused by heart muscle damage (“a heart attack”) from coronary ar…
Dilated cardiomyopathy (DCM) is a condition in which the heart becomes enlarged and the heart muscle weakened, causing the heart to pump blood less efficiently. DCM is commonly caused by heart muscle damage (“a heart attack”) from coronary artery disease. Other causes include exposure to some drugs, such as cancer chemotherapy. When the cause is unknown, it is called idiopathic DCM. Among individuals with idiopathic DCM, having relatives undergo a cardiac check-up (echocardiogram, ECG) will reveal familial DCM in up to one-third of cases. A high level of suspicion of familial DCM is also raised when family members have had heart failure, a heart transplant, sudden death (without a history of coronary artery disease), or arrhythmias, which sometimes require a pacemaker or defibrillator. WHAT DOES THIS STUDY INVOLVE? IF YOU HAVE IDIOPATHIC DCM: Participation involves inviting all your first-degree relatives (children, parents, siblings) with or without heart disease. If you have other more distant relatives with DCM, they are also welcome to participate. To help with this process, we provide a letter that you can share with your relatives, and a family history questionnaire for you to complete. You may also receive a communication tool to help you invite your family members to the study. Your participation also involves providing cardiovascular information and medical records, completing annual surveys, and a blood draw. FOR FAMILY MEMBERS: Participation of family members involves collecting cardiac information and a blood draw. To better understand the genetic cause of DCM, it is helpful to compare results from family members with and without the condition. Because DCM can be present but silent for years, it is difficult to know with certainty if a family member does or does not have DCM unless a cardiac check-up is performed. Medical guidelines recommend this for 1st degree family members of individuals with DCM. Therefore, we also ask family members who enroll to obtain cardiac screening with both an echocardiogram and an electrocardiogram (ECG) if they have not done so recently.
Inclusion Criteria:

Meeting criteria for dilated cardiomyopathy (DCM) :
Left ventricular ejection fraction 95%tile population standard based on gender and height).
Detectable causes of cardiomyopathy, except genetic, excluded beyond a reasonable doubt at the time of DCM diagnosis (that is, meeting clinical criteria for idiopathic DCM)
Any age (including children)
Non-Hispanic and Hispanic ethnicity
All races (PI pre-approval required for recruitment beyond pre-specified recruitment targets).
Ability to give informed consent
Ability to communicate in English (except Spanish language at sites approved to recruit individuals of Hispanic ethnicity)
Willingness to participate in a family-based study (patient willing to work with a clinical site and/or OSU to facilitate the recruitment and enrollment of family members to the study).

Exclusion Criteria:

Coronary artery disease (CAD) causing ischemic cardiomyopathy (> 50% narrowing, any major epicardial coronary artery)
Primary valvular disease
Adriamycin or other cardiotoxic drug exposure
Other forms of cardiomyopathy: Hypertrophic, Restrictive, or Arrhythmogenic Right Ventricular Dysplasia/Cardiomyopathy
Congenital heart disease
Other detectable causes of dilated cardiomyopathy, including sarcoid and hemochromatosis.
Other active multi-system disease that may cause DCM (e.g., active connective tissue disease).
Severe and untreated or untreatable hypertension (systolic blood pressures routinely greater than 180 mm Hg and/or diastolic blood pressures greater than 120 mm Hg, and if resistant to multidrug treatment).
However, conventional risk factors for DCM, including obesity, routinely treated hypertension, alcohol use, pregnancy or the peri-partum period, or left ventricular noncompaction, will NOT be considered exclusion criteria.
Wilcox, Jane ElizabethWilcox, Jane Elizabeth
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03037632 STU00205850
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Whisler, Cailin
TR Cardioband
This study is recruiting patients with tricuspid regurgitation (a condition in which blood flow through the tricuspid valve of the heart flows in the wrong direction) that may benefit from a new tricuspid valve reconstruction system. This is an early feasibility clinical research study …
This study is recruiting patients with tricuspid regurgitation (a condition in which blood flow through the tricuspid valve of the heart flows in the wrong direction) that may benefit from a new tricuspid valve reconstruction system. This is an early feasibility clinical research study that will evaluate the safety and performance of the Edwards Cardioband Tricuspid Valve Reconstruction System, (the “Study Device” ). The Study Device includes an adjustable implant that is delivered and anchored to the tricuspid valve by a transfemoral delivery system, meaning it is inserted in a minimally invasive procedure through a puncture into a vein in the leg. The Cardioband Implant will be positioned around the tricuspid valve and will be adjusted to reduce the size of the valve, thus improving the tricuspid regurgitation. Up to 15 patients will be enrolled in this study at up to 15 sites. All enrolled study patients will be assessed at the following intervals: screening/baseline, procedure, discharge, 1 month, 6 months, 1 year and annually for 5 years post implant procedure.
Davidson, Charles JDavidson, Charles J
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03382457 STU00207338
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McCloskey, Elizabeth
TRANSFORM-HF
This study is comparing torsemide to furosemide on long-term outcomes for patients that have been hospitalized for heart failure.  
  • Patients must be hospitalized with worsening of chronic heart failure, OR new diagnosis of heart failure with either recent LVEF < 40% (within past 24 months) or elevated BNP or NT-proBNP during index hospitalization
  • Plan for a daily outpatient oral loop diuretic regimen upon hospital discharge with anticipated long-term usage needed
  • >18 years of age
Rich, JonathanRich, Jonathan
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03296813 STU00207456
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Martinez, Leslie
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
PEA-Valve Study
The purpose of this study is to test whether data obtained from the Eko DUO and Eko CORE ElectronicStethoscope Systems and analysis of your heart sounds can identify valvular abnormalities usually foundby echocardiography. We wan…

The purpose of this study is to test whether data obtained from the Eko DUO and Eko CORE Electronic

Stethoscope Systems and analysis of your heart sounds can identify valvular abnormalities usually found

by echocardiography. We want to know whether listening to your heart with this device could be used in

place of an echocardiogram for screening certain heart conditions. Echocardiograms require highly

trained sonographers to capture images of your heart, as well as a cardiologist to interpret those images.

These devices can be easily used by any healthcare provider with minimal training, and a computer runs

the analysis so these devices may be able to provide a much simpler way of diagnosing certain types of

heart disease.

Inclusion:

  • Patients scheduled for a routine, full (i.e., not limited) clinical echocardiogram at Northwestern.
  • Patients ≥18 years old
  • Thomas, JamesThomas, James
    • Map it 201 East Huron Street Suite 12-160​
      Chicago, IL
    STU00208027
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    echo eko

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    Whisler, Cailin
    SHAPE
    Researchers are conducting a study to evaluate use of new software technology as a way to improve access to echocardiography (a non-invasive imaging procedure used to assess the heart's function and structures) and enhance heart disease detection …
    Researchers are conducting a study to evaluate use of new software technology as a way to improve access to echocardiography (a non-invasive imaging procedure used to assess the heart's function and structures) and enhance heart disease detection in the primary care setting.  The purpose of this study is to determine if medical assistants can obtain quality echocardiograms using new guidance software, called EchoGPS. The software proivdes feedback and visual assistance to users during the echo, helping them obtain clear, quality images. 

    Participants agreeing to participate will go to CDH for a single visit to have two echo exams:

    • Study Exam: A medical assistant will perform an echo using the EchoGPS guided assistance to obtain images.
    • Control Exam: A trained sonographer will perform a 2nd echo capturing the same views using without EchoGPS. 

    A cardiologist will compare the study echo to the control exam to evaluate quality of images. An unofficial report will be sent to the referring physician indicating any findings along with recommendations for follow-up.  Patients will receive a $50 gift card for participating. 

    Participants must meet following criteria:

    • Age 65 or over
    • Willing to have two echo exams during a single visit to Central DuPage Hospital (CDH)
    • Able to give consent
    • Present to your physician with one of the following: shortness of breath, swelling in the legs or a new heart murmur 

    McCarthy, Patrick MMcCarthy, Patrick M
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00207407
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    Whisler, Cailin
    CardiAMP

    The objective of this clinical trial is to determine the safety and efficacy of the CardiAMP cell therapy system in patients with post-myocardial infarction heart failure.

    Primary Inclusion:

  • NYHA II or III
  • A diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction (MI)
  • Have an ejection fraction ≥ 20% and ≤ 40% by twodimensional echocardiogram and not in the setting of a recent ischemic event
  • Primary Exclusion:

  • Have a baseline glomerular filtration rate < 30 ml/min /1.73m2
  • Have a hematological abnormality as evidenced by hematocrit < 30%, white blood cell < 4,500/μl or platelet values, <100,000/μl without another explanation
  • Anderson, AllenAnderson, Allen
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02438306 STU00206166
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    Roshevsky, Daniel Scott
    LEVO PH-HFpEF
    A Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients with Heart Failure and Preserved Left Ventricular Ejection Fraction (PH-HFpEF)

    Inclusion:

    1.Men or women, > 18 years of age 

    2.Confirmed diagnosis of WHO Group 2 Pulmonary Hypertension (PH) with heart failure and preserved ejection fraction (HFpEF). 

    3.WHO Group 2 Pulmonary Hypertension subjects with heart failure and preserved ejection fraction as defined by:

    • a. Mean pulmonary arterial pressure (mPAP) > 35 mmHg at rest or with legs up (at baseline right heart catheter/Lead-In)
    • b. Pulmonary capillary wedge pressure (PCWP) ≥ 20 mmHg at rest or with legs up (at baseline right heart catheter/Lead-In) 
    • c. NYHA Class II or III 
    • d. LVEF ≥ 40% by echocardiogram within three months of enrollment with no change in clinical status suggesting the potential for deterioration in systolic function 

    4.Signed (by the subjects or their legally acceptable representatives) informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. 

    5.Ability to walk at least 50 meters, but not more than 550 meters in a six-minute walk test. 

    6.Long term oxygen treatment (if applicable) must be stable for 30 days prior to enrollment. 

    7.Subjects on a chronic medication or therapy for any underlying cardiac condition must be on a stable dose for ≥30 days prior to randomization, with the exception of diuretics and antihypertensive medication for blood pressure control which may be discontinued if deemed appropriate. 

    8.Subjects on chronic medications for any underlying respiratory condition must be on a stable dose for ≥ 30 days prior to randomization 

    Exclusion:

    1.Previous PCI or cardiac surgery (CABG) unless documented to have a negative stress test within the last 12 months. 

    2.Clinically symptomatic mitral or aortic valvular heart disease. 

    3.Cardiac index greater than 4.0 L/min/m2 

    4.In the opinion of the Principal Investigator, the subject has a primary diagnosis of PH other than WHO Group 2 PH-HFpEF 

    5.Congenital heart disease other than surgically corrected pre and post tricuspid shunts for at least 5 years 

    6.Symptomatic coronary artery disease based on a positive stress test. 

    7.Patients planning lung or heart transplant; or cardiac surgery in the next 4 months 

    8.Patients diagnosed with pulmonary hypertension associated with clinically significant lung disease at the time of initial diagnosis, or patients with a congenital defect of the lung. 

    • a. Clinically significant obstructive lung disease is defined as FEV1/FVC <60% of predicted, unless a high resolution chest CT scan shows no more than mild areas of emphysematous changes. 
    • b. Clinically significant restrictive lung disease is defined as a FVC of <60% of predicted, unless a high resolution chest CT scan shows no more than mild areas of interstitial lung disease or pulmonary fibrosis. 

    9.Dialysis at randomization (either hemodialysis, peritoneal dialysis, continuous venovenous hemofiltration, or ultrafiltration) 

    10.Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 

    11.Liver dysfunction with Child Pugh Class B or C (see Attachment 3) 

    12.Evidence of systemic bacterial, systemic fungal, or viral infection in last 2 weeks 

    13.Weight >150 kg 

    14.Symptomatic low systolic blood pressure (SBP) that cannot be managed to ensure SBP > 100 mmHg at initiation of study drug 

    Rich, JonathanRich, Jonathan
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03541603 STU00208303
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    Roshevsky, Daniel Scott
    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%
  • Ricciardi, MarkRicciardi, Mark
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03706833 STU00208635
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    Brady, Caitlin
    CLASP TR EFS
    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 the condition or cure tricuspid regurgitation.  This …
    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 the condition or cure tricuspid regurgitation.  

    This is an early feasibility study, meaning patients agreeing to participate in this study will be one of the first patients in the USA to undergo repair of their tricuspid valve using this investigational (experimental) device system. The goal of this early feasibility study is to gain initial insight into the basic safety and performance of transluminal (through the blood vessels) implantation of the PASCAL System’s implant (composed of man-made materials). This study is being conducted in up to 8 US centers and will enroll 15 patients across all sites. 

     

    Participation in this research study will last about 5 years. 

    Davidson, Charles JDavidson, Charles J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03745313 STU00208923
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    McCloskey, Elizabeth
    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).&n…

    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