Northwestern University Feinberg School of Medicine

Department of Medicine

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 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. Principal Investigator Malaisrie, S. Chris Location(s) Map it 201 E. Huron St. Chicago, IL ClinicalTrials.gov IdentifierNCT03003299IRB number STU00204739 More Info Keywords Aortic Valve Transcatheter Aortic Valve Replacement (TAVR) Copy Study URL to Clipboard Copy
Quantitative Detection of Coronary Microvascular Dysfunction in Long COVID Patients Using a Comprehensive, Rapid, Free-Breathing Cardiovascular MRI This research study involves the use of Magnetic Resonance Imaging (MRI) to study the effectsof COVID-19 on the heart. Since COVID-19 is a new disease, we do not yet understand thedifferent ways that it may effect the body. There is some evidence that individuals with COVID-19 are … This research study involves the use of Magnetic Resonance Imaging (MRI) to study the effects of COVID-19 on the heart. Since COVID-19 is a new disease, we do not yet understand the different ways that it may effect the body. There is some evidence that individuals with COVID- 19 are at higher risk for heart complications. The purpose of this study is to use recently developed MRI techniques to compare heart health of individuals with COVID-19 to people who were asymptomatic or are healthy. The new MRI techniques used in this experiment may also allow researchers and health care providers to take clearer pictures of the heart in other individuals. Eligibility Criteria No kidney disease (eGFR is greater than 45) Does not have severe claustrophobia Principal Investigator Kim, Daniel Location(s) Map it 201 E. Huron St. Chicago, IL IRB number STU00205520 More Info Keywords MRI COVID COVID-19 Cardiac Heart Long COVID-19 Long COVID Email Starrett, Lane Noble Phone Copy Study URL to Clipboard Copy
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 Eligibility CriteriaPrimary 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 Principal Investigator Passman, Rod S Location(s) Map it 201 E. Huron St. Chicago, IL IRB number STU00207885 More Info Keywords Atrial Fibrillation (AFib) Pulmonary Vein Isolation (PVI) MRI Email Stat, Madison Rose Phone +1 312 926 3926 Copy Study URL to Clipboard Copy
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. Eligibility Criteria 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% Principal Investigator Davidson, Charles J Location(s) Map it 201 E. Huron St. Chicago, IL ClinicalTrials.gov IdentifierNCT03706833IRB number STU00208635 More Info Keywords Mitral Valve Regurgitation MVR Transcatheter Mitral Valve Repair TMVR MitraClip Email Patalino, Jessica Phone Copy Study URL to Clipboard Copy
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). Principal Investigator Freed, Benjamin Howard Location(s) Map it 201 E. Huron St. Suite 12 160 Chicago, IL IRB number STU00210998 More Info Keywords CTEPH CMR RV fibrosis RV Ischemia Email Davis, Lucia Phone Copy Study URL to Clipboard Copy
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. Eligibility Criteria 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 Principal Investigator Davidson, Charles J Location(s) Map it 201 E. Huron St. Chicago, IL ClinicalTrials.gov IdentifierNCT04198870IRB number STU00211557 More Info Keywords Heart Failure Heart Surgery Severe MR MitraClip MitralValve Repair Email Patalino, Jessica Phone Copy Study URL to Clipboard Copy
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. Principal Investigator Shah, Sanjiv J Location(s) Map it 201 E. Huron St. Chicago, IL ClinicalTrials.gov IdentifierNCT04136171IRB number STU00211443 More Info Keywords ATTR Transthyretin-Mediated Amyloid Cardiomyopathy ATTR CM Email San Emeterio, Lis Phone Copy Study URL to Clipboard Copy
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. Principal Investigator Davidson, Charles J Location(s) Map it 201 E. Huron St. Chicago, IL ClinicalTrials.gov IdentifierNCT04482062IRB number STU00213338 More Info Keywords Tricuspid Valve Transcatheter Email Cortez, Justin Phone 312 694 0298 Copy Study URL to Clipboard Copy
Precision MRI of Left Atrial Fibrosis for Patients with Atrial Fibrillation 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… 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 Eligibility Criteria Primary Inclusion Criteria: Patients ≥ 18 years old Patients with paroxysmal or persistent AF undergoing routine pulmonary vein isolation (PVI) Patients undergoing a cardiac MRI prior to AF ablation Primary Exclusion Criteria: Contraindication to MRI Abnormal renal function (eGFR < 60 mL/min/1.73 m2) Principal Investigator Kim, Daniel Location(s) Map it 710 N. Fairbanks Ct. Olson Pavilion Chicago, IL Map it 710 N. Fairbanks Court Chicago, IL IRB number STU00213834 More Info Keywords Atrial Fibrillation (Afib) Pulmonary Vein Isolation (PVI) MRI Catheter Ablation Email McKenzie, Alexis Phone Copy Study URL to Clipboard Copy
CY6022 A FOLLOW-UP, OPEN-LABEL, RESEARCH EVALUATION OF SUSTAINED TREATMENT WITH AFICAMTEN (CK3773274) IN HYPERTROPHIC CARDIOMYOPATHY (HCM) Eligibility Criteria 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% Principal Investigator Choudhury, Lubna Location(s) Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100 Chicago, IL ClinicalTrials.gov IdentifierNCT04848506IRB number STU00214844 More Info Keywords HCM Email Yang, Jason Phone Copy Study URL to Clipboard Copy
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. Principal Investigator Benzuly, Keith H Location(s) Map it 201 E. Huron St. Chicago, IL ClinicalTrials.gov IdentifierNCT04763200IRB number STU00214880 More Info Keywords HFrEF Heart Failure with Reduced EF PCI Email Roshevsky, Daniel Scott Phone Copy Study URL to Clipboard Copy
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. Eligibility Criteria 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 Principal Investigator Freaney, Priya M. Location(s) Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100 Chicago, IL ClinicalTrials.gov IdentifierNCT05180773IRB number STU00217144 More Info Keywords Cardiomyopathy Bromocriptine Email Subhani, Safa Samar Phone Copy Study URL to Clipboard Copy
REACT-AF Rhythm Evaluation for AntiCoagulaTion with Continuous Monitoring of Atrial Fibrillation Eligibility Criteria Documented history of symptomatic or asymptomatic paroxysmal or persistent AF CHA2DS2-VASC score of 1-4 without prior stroke or TIA Participant is on a DOAC at time of screening Principal Investigator Knight, Bradley Paul Location(s) Map it 1000 N. Westmoreland Road Main Entrance Lake Forest, IL Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100 Chicago, IL ClinicalTrials.gov IdentifierNCT05836987IRB number STU00219005 More Info Keywords Paroxysmal Persistent AF Apple Watch Email Stat, Madison Rose Phone +1 312 926 3926 Copy Study URL to Clipboard Copy
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 Eligibility Criteria Diagnosed with oHCM per study criteria by cardiac magnetic resonance imaging (CMR) or echocardiography Principal Investigator Choudhury, Lubna Location(s) Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100 Chicago, IL ClinicalTrials.gov IdentifierNCT05767346IRB number STU00219019 More Info Keywords HCM Email Yang, Jason Phone Copy Study URL to Clipboard Copy
SEISMIC-HF I Non-invasive Seismocardiogram In Cardiovascular monitoring for Heart Failure I Eligibility Criteria History of heart failure or suspected heart failure Scheduled to undergo a right heart catheterization (RHC) procedure Willing to wear the CardioTag device during their RHC procedure Principal Investigator Tibrewala, Anjan Location(s) Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100 Chicago, IL ClinicalTrials.gov IdentifierNCT00000000IRB number STU00215330 More Info Keywords Cardio Tag Seismic Email Silverman, Andrea Raye Phone Copy Study URL to Clipboard Copy
CY 6033 ACACIA TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF AFICAMTEN COMPARED TO PLACEBO IN ADULTS WITH SYMPTOMATIC NONOBSTRUCTIVE HYPERTROPHIC CARDIOMYOPATHY Principal Investigator Choudhury, Lubna Location(s) Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100 Chicago, IL ClinicalTrials.gov IdentifierNCT06081894IRB number STU00219608 More Info Keywords HCM Non-Obstructive HCM AFICAMTEM Email Yang, Jason Phone Copy Study URL to Clipboard Copy
Pulmonary Artery DenerVation Clinical Study using the Gradient Denervation System in Heart Failure Patients with Pulmonary Hypertension Group 2 (PreVail-PH2 Study) Prospective, single arm, multi-center, early feasibility study to characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Group 2 Pulmonary Hypertension… Prospective, single arm, multi-center, early feasibility study to characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Group 2 Pulmonary Hypertension Eligibility Criteria Ambulatory with an age of 22-85 years at time of enrollment Heart Failure with EF ≥ 40% (by TTE within last 3 months) NYHA Class II or III Principal Investigator Schimmel, Daniel Richard Location(s) Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100 Chicago, IL ClinicalTrials.gov IdentifierNCT06052072IRB number STU00220161 More Info Keywords Pulmonary Hypertension Email Novak, Nicole Phone Copy Study URL to Clipboard Copy
MAGNITUDE A Phase 3, Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NTLA-2001 in Participants with Transthyretin Amyloidosis with Cardiomyopathy Eligibility Criteria Diagnosis of ATTR-CM Medical history of HF Treatment for HF/ATTR-CM is optimized and symptoms are clinically stable Principal Investigator Shah, Sanjiv J Location(s) Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100 Chicago, IL ClinicalTrials.gov IdentifierNCT06128629IRB number STU00220347 More Info Keywords ATTR Transthyretin amyloidosis Email Cortez, Justin Phone Copy Study URL to Clipboard Copy
VOLT-AF IDE The objective of the VOLT-AF study is to demonstrate that the Volt™ PFA System (Volt PFA System) is safe and effective for the treatment of symptomatic, recurrent, drug refractory paroxysmal and persistent atrial fibrillation (AF). Eligibility Criteria Documented symptomatic PAF or PersAF Plans to undergo a PVI catheter ablation procedure due to symptomatic PAF or PersAF Principal Investigator Knight, Bradley Paul Location(s) Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100 Chicago, IL ClinicalTrials.gov IdentifierNCT06223789IRB number STU00221001 More Info Keywords PAF Atrial Fibrillation Email George, Neal Phone Copy Study URL to Clipboard Copy