Cardiology Clinical Trials
The following searchable list includes all the Division of Cardiology, Department of Medicine clinical trials currently looking for participants. Please feel free to contact us with inquiries about any of our ongoing research.
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Partner 3 AVIV RegistryThis 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. |
Quantitative Detection of Coronary Microvascular Dysfunction in Long COVID Patients Using a Comprehensive, Rapid, Free-Breathing Cardiovascular MRIIfsuccessful, this study will produce an accurate, 15-minute MRI test for gatekeepingcardiac catheterization, thereby minimizing risks and costs of unnecessarycatheterization. This study is also technologically significant because itwill produce rapid MRI acquisition and reconstruction methods aimed atovercoming three long-standing barriers to widespread use of cardiovascularMRI: (i) long scan … Ifsuccessful, this study will produce an accurate, 15-minute MRI test for gatekeepingcardiac catheterization, thereby minimizing risks and costs of unnecessarycatheterization. This study is also technologically significant because itwill produce rapid MRI acquisition and reconstruction methods aimed atovercoming three long-standing barriers to widespread use of cardiovascularMRI: (i) long scan time, (ii) complex scanning, and (iii) sensitivity toarrhythmia. Aim 1: 1. 2. 3. 4. Noovert history of cardiovascular disease (normal/controls) – OR - prior historyof myocardial infarction, respectively STU00205520 |
AF STOP: AF Substrate as an Outcome and Predictor of successful AF ablationTo improve the understanding of factors associated with the atrial myopathy in people with AF or people at risk for developing AF Primary Inclusion Criteria:
Primary Exclusion Criteria:
STU00207885 |
CLASP IID/IIFThe 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:
NCT03706833 STU00208635 |
RV Ischemia & Fibrosis in CTEPHThis 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). |
REPAIR-MRThe 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.
NCT04198870 STU00211557 |
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. |
ALL-INThis 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
NCT03644667 STU00212222 |
TRISCEND IIThis 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. |
iCLAS™ for Persistent Atrial FibrillationThis 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. |
DEFINE AfibThis 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. |
Precision MRI of Left Atrial Fibrosis for Patients with Atrial FibrillationTo develop new MRI approaches that can better quantify the severity of left atrial fibrosis, for the purposes of predicting whether patients will revert to atrial fibrillation (AF) following an initial successful procedure… To develop new MRI approaches that can better quantify the severity of left atrial fibrosis, for the purposes of predicting whether patients will revert to atrial fibrillation (AF) following an initial successful procedure Primary Inclusion Criteria:
Primary Exclusion Criteria:
STU00213834 |
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.
NCT04766892 STU00213899 |
CY6022A FOLLOW-UP, OPEN-LABEL, RESEARCH EVALUATION OF SUSTAINED TREATMENT WITH AFICAMTEN (CK3773274) IN HYPERTROPHIC CARDIOMYOPATHY (HCM)
NCT04848506 STU00214844 |
DCM (MYK-491-006)This study is recruiting patients aged 18-80 years and who have been diagnosed with dilated cardiomyopathy due to a mutation in either MYH7 or TTN, both of which are genes involved in the function of heart muscle. The purpose of Part A of this study is to evaluate the … This study is recruiting patients aged 18-80 years and who have been diagnosed with dilated cardiomyopathy due to a mutation in either MYH7 or TTN, both of which are genes involved in the function of heart muscle. The purpose of Part A of this study is to evaluate the safety, tolerability, and cardiac pharmacodynamics (the effect of the drug on your heart) of the study drug, danicamtiv, when administered by mouth twice a day for approximately one to two weeks. Once you complete Part A of the study, you will have the option to continue onto Part B of the study and receive study drug for approximately another 96 weeks. Danicamtiv is being developed to improve the pumping function of the heart muscle for subjects with large hearts that do not pump blood as well as normal hearts, known as dilated cardiomyopathy, and heart failure with reduced ejection fraction (the heart cannot pump enough blood to meet the body's needs). |
IMPROVE-HCMThis study is recruiting patients with a diagnosis of hypertrophic cardiomyopathy (HCM) who are able to perform a treadmill cardiopulmonary exercise test. The safety and tolerability of investigative study drug IMB-1018972 is being studied in patients with non-obstructive hypertrophic cardiomyopathy. This study will also exmaine the effect … This study is recruiting patients with a diagnosis of hypertrophic cardiomyopathy (HCM) who are able to perform a treadmill cardiopulmonary exercise test. The safety and tolerability of investigative study drug IMB-1018972 is being studied in patients with non-obstructive hypertrophic cardiomyopathy. This study will also exmaine the effect of IMB-1018972 on exercise capacity and how the heart uses energy. |
PROTECT IV TrialThis 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. |
Corcinch-HFThe purpose of this study is to assess the safety and effectiveness of the AccuCinch Ventricular Restoration System and compare it to standardized heart failure medications. The AccuCinch Ventricular Restoration System is an investigational (experimental) device intended to treat patients who are experiencing symptoms of heart failure due to … The purpose of this study is to assess the safety and effectiveness of the AccuCinch Ventricular Restoration System and compare it to standardized heart failure medications. The AccuCinch Ventricular Restoration System is an investigational (experimental) device intended to treat patients who are experiencing symptoms of heart failure due to a dilated (enlarged) left ventricle (heart chamber which pumps blood).
NCT04331769 STU00214441 |
LUX-Dx TRENDSThis 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. |
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.
NCT05017935 STU00216609 |
REBIRTHThe 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.
NCT05180773 STU00217144 |
RESPONDER-HFRe-Evaluation of the Corvia Atrial Shunt Device in a Precision Medicine Trial to Determine Efficacy in Mildly Reduced or Preserved EF Heart Failure
NCT05425459 STU00217812 |
RIVUS HuMAIN (RIV-HU6-2201)Exploratory Phase 2A, Double-Blind, Placebo-Controlled Dose Escalation Study to Determine the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of HU6 for the Treatment of Subjects with Obese Heart Failure with Preserved Ejection Fraction
NCT05284617 STU00217735 |
CY 6032A 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
NCT05767346 STU00219019 |