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Clinical Trials

Investigators at the Bluhm Cardiovascular Institute’s Clinical Trials Unit (BCVI-CTU) conduct clinical research trials on all aspects of heart and vascular disease. 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.

The following searchable list includes all Department of Medicine clinical trials currently looking for participants. Find information on participating in the research done through the BCVI-CTU via our Frequently Asked Questions page. For more information about our clinical trials, please contact the CTU Regulatory Team.

Trials

MISCEND

This study is enrolling patients with moderate to severe mitral regurgitation who are considered to have high surgical 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 …
This study is enrolling patients with moderate to severe mitral regurgitation who are considered to have high surgical 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 assess the safety and performance of a new bioprosthetic mitral valve device when implanted through groin (transfemoral) access. The new mitral valve replacement device is called the Edwards EVOQUE Eos System. The Edwards EVOQUE Eos 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 (transfemoral/transseptal).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 7 scheduled study visits after discharge from the hospital at 1, 6, 12, 24, 36, 48 and 60 months after the procedure.
Patients with moderate to severe mitral regurgitation who are considered to have high surgical risk for traditional open-heart surgery. General Criteria:1. Greater than or equal to 18 years of age.2. New York Heart Associate Classification ≥ II3. Left Ventricular Ejection Fraction ≥ 30%.4. Mitral regurgitation (MR) ≥ Grade 3+ (moderate/severe, or severe).5. Patient is determined to be high surgical risk as assessed by the site’s ‘Heart Team’ (a minimum of one Cardiac Surgeon and one Interventional Cardiologist). 
Davidson, Charles JDavidson, Charles J
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02718001 STU00204104
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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). Blood flows …
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 conditionThe 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.

Presence of thoracic aortic pathology deemed to warrant surgical repair which requires proximal graft placement in Zone 0-2

Hoel, Andrew WarfieldHoel, Andrew Warfield
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02777593 STU00203850
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Partner 3 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 SAPIEN 3 transcatheter aortic heart valve (study device) to replace …
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.
Malaisrie, S. ChrisMalaisrie, S. Chris
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03003299 STU00204739
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APOLLO

This study is enrolling subjects with at least moderate-to-severe symptomatic mitral regurgitation to test a new investigational device for mitral regurgitation. A separate study cohort (MAC Cohort) will enroll subjects with at least moderate symptomatic mitral regurgitation combined with mitral stenosis in the presence of mitral annular calcification (…
This study is enrolling subjects with at least moderate-to-severe symptomatic mitral regurgitation to test a new investigational device for mitral regurgitation. A separate study cohort (MAC Cohort) will enroll subjects with at least moderate symptomatic mitral regurgitation combined with mitral stenosis in the presence of mitral annular calcification (MAC). The new investigational device is a mitral valve replacement called the Medtronic 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 IntrepidTM 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. Participation in this study will last for approximately 5 years. Participants will be expected to attend a minimum of 7 in-person scheduled study visits after discharge from the hospital at 1, 6, 12, 24, 36, 48 and 60 months after the procedure.
Enrolling participants with mitral valve regurgitation who 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 have determined that these participants 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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AF STOP: AF Substrate as an Outcome and Predictor of successful AF ablation

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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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 determined to be at prohibitive risk for …
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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    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 a narrow opening into a small incision …
    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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    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 blood pressure in the arteries in the pulmonary system (lungs) caused by clots. Over time …
    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 E. Huron St. Suite 12 160​
      Chicago, IL
    STU00210998
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    Davis, Lucia
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    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 body. This research …
    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 E. Huron St. Suite 12 160​
      Chicago, IL
    NCT03728985 STU00211408
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    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 MitraClip System uses a less …
    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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    Angiotensin II for Distributive Shock

    Angiotensin II as a first-line vasopressor for distributive shock for heart transplant and left ventricular assist device implantation recipients: A Pilot Study

    Onset of distributive shock within 48 hours after heart transplantation or VAD placement at Northwestern Memorial Hospital

    Lewis, Choy Rae AvaLewis, Choy Rae Ava
    • Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100
      Chicago, IL
    NCT04904562 STU00211528
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    Cardio-TTRansform (ION-682884-CS2)

    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 …
    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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    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 defenses to protect against disease) …

    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.

    Patients who are about to have a heart transplant

    Ghafourian, KambizGhafourian, Kambiz
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03644667 STU00212222
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    Prospective evaluation of an applied ATTR-CM Machine Learning model to a health system electronic health record (EHR)

    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. …

    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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    TRISCEND II

    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 …
    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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    iCLAS™ for Persistent Atrial Fibrillation

    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 …
    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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    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 failure is not responding well to …
    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.

    Chronic heart failure defined as:

    a. Symptoms of HF requiring current treatment (intermittent or continuous) with diuretics for > 30 days,

    AND

    b. NYHA class II with a history of > NYHA class II in the past year, NYHA class III, or ambulatory NYHA class IV symptoms (paroxysmal nocturnal dyspnea, orthopnea, dyspnea on mild or moderate exertion) at screening; or signs of HF (any rales post cough, chest x-ray demonstrating pulmonary congestion),

    Patel, Ravi BPatel, Ravi B
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04592445 STU00213774
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    Catalyst

    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 …
    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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    DEFINE Afib

    This study is recruiting patients who have a Medtronic Reveal LINQ or LINQ II (or other market-released model) Insertable Cardiac Monitor (ICM) device to monitor their Atrial Fibrillation (Afib).  The study will be collecting data entered from the Medtronic Discovery App, data from the LINQ ICM device, and, …
    This study is recruiting patients who have a Medtronic Reveal LINQ or LINQ II (or other market-released model) Insertable Cardiac Monitor (ICM) device to monitor their Atrial Fibrillation (Afib).  The study will be collecting data entered from the Medtronic Discovery App, data from the LINQ ICM device, and, if allowed, data from the Apple Health app on your iPhone.  The purpose of this study is to both better understand how certain factors affect patterns of Afib; and how each patient's Afib impacts their daily life, quality of life, Afib symptoms, and healthcare usage.  
    Patil, Kaustubha DilipPatil, Kaustubha Dilip
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00214493
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    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 heart failure and whose heart is …
    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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    EMBARK (MYK-461-019)

    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” …
    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.
    • Documented prior objective evidence of heart failure as defined in the study protocol
    • At least 50 years old and body weight > 45 kg
    Patel, Ravi BPatel, Ravi B
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04766892 STU00213899
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    MRI vs Echo: MR-TR

    This study is recruiting patients who have had or are scheduled to have an intervention to repair or replace their mitral or tricuspid valve.  The purpose of this study is to improve the assessment of mitral or tricuspid regurgitation before and after percutaneous or surgical intervention.…
    This study is recruiting patients who have had or are scheduled to have an intervention to repair or replace their mitral or tricuspid valve.  The purpose of this study is to improve the assessment of mitral or tricuspid regurgitation before and after percutaneous or surgical intervention.
    Thomas, James DavidThomas, James David
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00214668
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    CY6022

    A FOLLOW-UP, OPEN-LABEL, RESEARCH EVALUATION OF SUSTAINED TREATMENT WITH AFICAMTEN (CK3773274) IN HYPERTROPHIC CARDIOMYOPATHY (HCM)

    • Completion of a Cytokinetics study investigating CK-3773274. If unable to complete due to circumstances not related to compliance or safety, Medical Monitor may review and determine eligibility.
    • LVEF ≥ 55%
    Choudhury, LubnaChoudhury, Lubna
    • Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100
      Chicago, IL
    NCT04848506 STU00214844
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    HCM
    Yang, Jason
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    PROTECT IV Trial

    This study is recruiting patients who are scheduled to have a heart procedure called a Percutaneous Coronary Intervention (PCI) and may be at risk of potential problems during the procedure because they have complex heart disease and reduced left heart function.  The purpose of this study is to assess …
    This study is recruiting patients who are scheduled to have a heart procedure called a Percutaneous Coronary Intervention (PCI) and may be at risk of potential problems during the procedure because they have complex heart disease and reduced left heart function.  The purpose of this study is to assess if using an Impella device during high-risk PCI in patients with reduced left-sided heart function will result in an improvement in symptoms, heart function, and health after the heart procedure compared to the current standard of care.  
    Benzuly, Keith HBenzuly, Keith H
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04763200 STU00214880
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    LUX-Dx TRENDS

    This study is recruiting patients whose medical tests show they have heart failure, and whose doctors have determined that they would benefit from an insertable cardiac monitor (ICM).  Heart Failure is a condition that makes the heart muscle weak and the heart cannot pump as much blood as the …
    This study is recruiting patients whose medical tests show they have heart failure, and whose doctors have determined that they would benefit from an insertable cardiac monitor (ICM).  Heart Failure is a condition that makes the heart muscle weak and the heart cannot pump as much blood as the body needs.  Sensors have been added to the ICM to determine whether they can provide doctors who treat patients with similar conditions with additional information to help analyze their heart failure condition.  The study will gather information about the sensors.  
    Okwuosa, Ike StanleyOkwuosa, Ike Stanley
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04790344 STU00214908
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    PROACTIVE-HF

    Evaluating the Safety and Efficacy of the Cordella™ Pulmonary Artery Sensor System
  • Diagnosis and treatment of HF (regardless of left ventricular ejection fraction (LVEF)) for ≥ 3 months and NYHA Class III HF at time of screening
  • stable, optimally titrated medical therapy for at least 30 days
  • HF related hospitalization within 12 month (last hospitalization should be 30 days before Screening/Enrollment) and/or N-terminal pro B-type Natriuretic Peptide (NTproBNP) at time of Screening/ Enrollment defined as:
  • Subjects with LVEF ≤ 50%: NT-proBNP ≥ 1500 pg/mL.
  • Subjects with LVEF > 50%: NT-proBNP ≥ 800 pg/mL
  • Raza, YasminRaza, Yasmin
    • Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100
      Chicago, IL
    NCT04089059 STU00216044
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    Impella BTR EFS

    Use of the Impella BTR™ in Patients with Heart Failure: An Early Feasibility Study

    • Subject has pre-existing heart failure, with NYHA Class IV prior to the index admission
    • Presenting with acute heart failure and meets one of the following criteria:
    • Sustained episode of systolic blood pressure ≤90 mmHg for at least 30 minutes or need for vasoactive agents to maintain such blood pressure
    • Or a cardiac index (CI) <2.2 L/min/m2 determined to be secondary to cardiac dysfunction, in the absence of hypovolemia
    • Or required support with an intra-aortic balloon pump
    Pham, Duc ThinhPham, Duc Thinh
    NCT05291884 STU00216603
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    RADIANCE Continued Access Protocol (RADIANCE CAP)

    RADIANCE CAP is a non-randomized study designed to allow for continued access to ultrasound renal denervation therapy via the Paradise System, and to allow for the on-going collection of safety and effectiveness data in subjects with uncontrolled hypertension despite the prescription of antihypertensive medications.…

    RADIANCE CAP is a non-randomized study designed to allow for continued access to ultrasound renal denervation therapy via the Paradise System, and to allow for the on-going collection of safety and effectiveness data in subjects with uncontrolled hypertension despite the prescription of antihypertensive medications.

    Benzuly, Keith HBenzuly, Keith H
    • Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100
      Chicago, IL
    NCT05017935 STU00216609
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    REBIRTH

    The study will enroll women newly diagnosed with peripartum cardiomyopathy within 5 months postpartum in a randomized trial of bromocriptine therapy to evaluate its impact on myocardial recovery.

  • Presentation with a new diagnosis of peripartum cardiomyopathy
  • Post-delivery and within the first 5 months post-partum.
  • Clinical assessment of an LVEF < 0.35 within 2 weeks of consent
  • Freaney, Priya M.Freaney, Priya M.
    • Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100
      Chicago, IL
    NCT05180773 STU00217144
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    PERSEVERE

    To assess the safety and effectiveness of AMDS to treat patients with acute DeBakey type I dissection with evidence of radiographic and/or clinical malperfusion, through open surgical repair.

    • Acute DeBakey type I dissection based on computed tomography angiography (CTA) and diagnosed ≤14 days from of the index event
    • Presence of malperfusion (cerebral, visceral, renal, spinal cord, and/or peripheral)
    Malaisrie, S. ChrisMalaisrie, S. Chris
    • Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100
      Chicago, IL
    NCT05174767 STU00216770
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    DEFINE-HT

    DevelopmEnt of non-invasive cell-Free DNA to supplant INvasivE biopsy in Heart Transplantation (DEFINE-HT)

    Undergoing transplant evaluation or currently on the heart transplant waiting list and expected to receive a heart transplant.

    Ghafourian, KambizGhafourian, Kambiz
    NCT05309382 STU00217683
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    LeAAPS Trial

    Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial

    • Documentation of any of the following clinical criteria:
    • CHA2DS2-VASc ≥ 4 with age ≥ 65
    • CHA2DS2-VASc ≥ 4 with significant left atrium enlargement or elevated NT-proBNP *
    • CHA2DS2-VASc = 3 with age ≥ 75
    • CHA2DS2-VASc = 3 with significant left atrium enlargement or elevated NT-proBNP *
    • CHA2DS2-VASc score = 2 with age ≥ 65 and significant left atrium enlargement or elevated NT-proBNP *
    • Significant left atrium enlargement or elevated NT-proBNP
    McCarthy, Patrick MMcCarthy, Patrick M
    • Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100
      Chicago, IL
    NCT05478304 STU00217732
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    Stroke LAA
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    REHAB-HFpEF

    Physical Rehabilitation for Older Patients with Acute Heart Failure with Preserved Ejection Fraction (REHAB-HFpEF)

    • Ejection Fraction >=45%
    • In the hospital setting >24 hours for the management of acute decompensated heart failure (ADHF), or diagnosed with ADHF after being hospitalized for another reason
    Patel, Ravi BPatel, Ravi B
    • Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100
      Chicago, IL
    • Map it 355 E. Erie St.
      Chicago, IL
    STU00218196
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    ADVANTAGE-AF

    A Prospective Single Arm Open Label Study of the FARAPULSE Pulsed Field Ablation System in Subjects with Persistent Atrial Fibrillation

    Subjects having symptomatic, documented, drug-resistant, Persistent AF

    Lin, Albert Chao-tunLin, Albert Chao-tun
    • Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100
      Chicago, IL
    NCT05443594 STU00217834
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    RESPONDER-HF

    Re-Evaluation of the Corvia Atrial Shunt Device in a Precision Medicine Trial to Determine Efficacy in Mildly Reduced or Preserved EF Heart Failure

    • Chronic symptomatic heart failure (HF)
    • Ongoing stable GDMT HF management and management of comorbidities according to the 2022 ACC/AHA Guidelines for the Management of Heart Failure.
    Flaherty, James DFlaherty, James D
    • Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100
      Chicago, IL
    NCT05425459 STU00217812
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    CY 6032

    A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF AFICAMTEN COMPARED TO METOPROLOL IN ADULTS WITH SYMPTOMATIC OBSTRUCTIVE HYPERTROPHIC CARDIOMYOPATHY

    Diagnosed with oHCM per study criteria by cardiac magnetic resonance imaging (CMR) or echocardiography

    Choudhury, LubnaChoudhury, Lubna
    • Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100
      Chicago, IL
    NCT05767346 STU00219019
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    HCM
    Yang, Jason
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    CY 6033 ACACIA

    TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF AFICAMTEN COMPARED TO PLACEBO IN ADULTS WITH SYMPTOMATIC NONOBSTRUCTIVE

    HYPERTROPHIC CARDIOMYOPATHY

    Choudhury, LubnaChoudhury, Lubna
    • Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100
      Chicago, IL
    NCT06081894 STU00219608
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    Yang, Jason
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    Equity in Modifying Plaque Of WomEn with UndeRtreated Calcified Coronary Artery Disease (EMPOWER CAD)

    The purpose of the study is to further assess the safety and effectiveness of the Shockwave Coronary IVL system (“Study Device”) in the arteries of your heart.

    Sweis, Ranya NabilSweis, Ranya Nabil
    NCT05755711 STU00219788
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    Shockwave PCI
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