Heart & Vascular Clinical Trials

Explore our current clinical trials for heart & vascular:

[Updated: 12/5/25]

Electrophysiology

Librexia – AF

Status:
Follow up

Summary:
A Study of Milvexian Versus Apixaban in Participants with Atrial Fibrillation

Description:
A phase 3, Randomized, Double-blind, Study to evaluate the efficacy and safety of Milvexian, an Oral Factor Xia Inhibitor vs. Apixaban in patients with Atrial Fibrillation.

Pre-Determine

Status:
Enrolling

Summary:
PRE-DETERMINE Cohort Study

Description:
This is a prospective, multi-center cohort study of patients with a history of coronary artery disease (CAD) and documentation of either a prior myocardial infarction (MI) or mild to moderate left ventricular dysfunction (LVEF 35-50%). The primary objective of this study is to determine whether biologic markers and ECGs can be utilized to advance SCD risk prediction in patients with CHD and LVEF>30-35%. The overarching goal of the study is to identify a series of markers that alone or in combination specifically predict risk of arrhythmic death as compared to other causes of mortality among this at risk population of coronary heart disease (CHD) patients with preserved left ventricular ejection fraction (LVEF> 30-35%). If biologic or ECG markers are identified that can specifically predict risk of ventricular arrhythmias, then these markers may serve as relatively inexpensive methods to identify those at risk. The public health impact of identifying markers could be quite substantial, leading to more efficient utilization of ICDs and advances in our understanding of mechanisms underlying SCD.

General Cardiology

VICTORION-2P

Status:
Follow-up

Summary:
Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease

Description:
This study is a pivotal Phase III trial to evaluate the benefits of inclisiran on major adverse cardiovascular (MACE) events in participants with established cardiovascular disease (CVD).

Heart Failure

Cardiogenic Shock Working Group

Status:
Enrolling

Summary:
Cardiogenic Shock Working Group Registry

Description:
The Cardiogenic Shock Working Group is a multicenter registry where we collect de-identified clinical variables from the medical records and follow-up phone calls of shock patients from multiple institutions and centralize this data to a single registry for analysis of clinical outcomes.

Elevate HF

Status:
Enrolling

Summary:
Evaluation Of A Virtual Cardiology Program To Improve Outcomes After Acute Decompensated Heart Failure: The ELEVATE-HF Randomized Controlled Trial

Description:
The purpose of this study is to evaluate how safe and effective a remote, virtual, cardiology program is that provides heart failure education to patients, monitors for worsening heart failure, and quickly adjusts heart failure medications, compared to usual care medication use and adjustment, in participants with decompensated heart failure that are recently hospitalized.

REVAMP DORAYA-HF

Status:
Enrolling

Summary:
Doraya-HF: Assessment of the Doraya Device for the treatment of volume overload in Acute Heart Failure Patients with Insufficient Response to Diuretics

Description:
The study objective is to evaluate the feasibility of the Doraya Catheter and measure clinical performance and safety endpoints, in ADHF patients deemed to have insufficient diuretic response.

V-Wave RELIEVE-HF

Status
Follow-up

Summary
Reducing Lung CongestIon Symptoms in Advanced Heart Failure (RELIEVE-HF)

Description
This is a prospective, multi-center, 1:1 randomized, patient and observer blinded clinical study, with a Shunt Treatment arm and a non-implant Control arm. The study device, the V-Wave Interartrial Shunt System, includes a permanent implant – the Shunt. The Shunt is placed during a minimally invasive cardiac catheterization procedure using its dedicated Delivery Catheter. By transferring blood from the left to the right atrium, the Shunt is intended to reduce excessive left-sided cardiac filling pressures in patients with advanced Heart Failure.

Reprieve (FASTR II)

Status
Follow-up

Summary
Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System

Description
The objective of this study is to prospectively compare decongestive therapy administered by the Reprieve System to Optimal Diuretic Therapy (ODT) in the treatment of patients diagnosed with acute decompensated heart failure (ADHF). The main objective is to determine if the Reprieve System can more efficiently decongest ADHF patients in comparison to Control Therapy.

Interventional Cardiology

Artemis

Status:
Enrolling

Summary:
Effects of ziltivekimab versus placebo on cardiovascular outcomes in patients with acute myocardial infarction

Description:
The research study is being done to see if ziltivekimab can be used to treat people who were admitted to hospital because of a heart attack. Ziltivekimab might reduce development of heart disease, thereby preventing new heart attacks or strokes. Participants will either get ziltivekimab (active medicine) or placebo (a dummy medicine which has no effect on the body). Which treatment participants get is decided by chance. The chance of getting ziltivekimab or placebo is the same. The participant will need to inject the study medicine into a flat skin surface in there stomach, thigh, or upper arm once every month. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe. The study will last for about 2 years.

Medtronic-PSR

Status:
Follow-up

Summary:
Surveillance Registry for Medtronic Coronary Post-Surveillance

Description:
A registry for the collection of data on coronary percutaneous interventions to help fulfill the new European Medical Devices Regulation requirements.

Fracture (Bolt Medical)

Status:
Enrolling

Summary:
Modification of Coronary Calcium With Laser Based Intravascular Lithotripsy for Coronary Artery Disease (FRACTURE)

Description:
The FRACTURE Trial is a prospective, non-randomized, single-arm, multicenter, interventional study in US and international centers with the Bolt Intravascular Lithotripsy System that was designed to percutaneous transluminal angioplasty by utilizing delivery of IVL to disrupt calcium prior to full balloon dilatation at low pressures.

DEFINE GPS/Define ChiL

Status:
Follow up

Summary:
Distal Evaluation of Functional Performance With Intravascular Sensors to Assess the Narrowing Effect: Guided Physiologic Stenting

Description:
Define ChiL is a sub study of the Define GPS study. This multi-center, prospective, randomized controlled study compares PCI guided by angiography versus iFR Co-Registration using commercially available Philips pressure guidewires and the SyncVision co-registration system.

IMPROVE MedStar Health Research

Status:
Follow up

Summary:
Impact on Revascularization Outcomes of IVUS Guided Treatment of Complex Lesions and Economic Impact (IMPROVE)

Description:
This is a prospective, single-blind clinical investigation randomizing subjects to intravascular ultrasound (IVUS)-guided coronary stent implantation vs. angiography-guided coronary stent implantation in a 1:1 ratio.

Discover INOCA Study

Status:
Enrolling

Summary:
The DISCOVER INOCA Prospective Multi-center Registry

Description:
The overall objective of this multi-center registry is to identify specific phenotypes of INOCA with both an anatomic evaluation (coronary angiography and intravascular imaging) and physiologic assessment with the Abbott Coroventis Coroflow Cardiovascular System, and to determine long-term outcomes.

Librexia – ACS Janssen ACS Trial

Status:
Enrolling

Summary:
A Study of Milvexian in Participants After a Recent Acute Coronary Syndrome

Description:
A Phase 3, randomized, double blind, placebo controlled, event driven study to demonstrate the efficacy and safety of Milvexian, an Oral Factor Xia Inhibitor, after a recent ACS.

COSIRA II

Status:
Enrolling

Summary:
Efficacy of the Coronary SInus Reducer in Patients With Refractory Angina II (COSIRA-II)

Description:
To demonstrate the safety and effectiveness of the Shockwave Reducer for treatment of patients with refractory angina pectoris treated with maximally tolerated guideline-directed medical therapy who demonstrate objective evidence of reversible myocardial ischemia in the distribution of the left coronary artery and who are deemed unsuitable for revascularization. A non-randomized single-arm registry will further assess the safety and effectiveness of the Shockwave Reducer in selected subjects with reversible myocardial ischemia in the distribution of the right coronary artery and who are deemed unsuitable for revascularization, subjects without documented obstructive coronary disease and abnormal coronary flow reserve (ANOCA), and subjects who cannot complete an exercise tolerance test due to lower limb amputation (above the ankle) or other physiologic condition with documented chronic mobility or balance issues that require the use of a walking aid.

Triton-CM

Status:
Enrolling

Summary:
A Study to Evaluate Nucresiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy

Description:
The purpose of this study is to:

  • Evaluate the efficacy of nucresiran compared to placebo on reducing all-cause mortality and cardiovascular (CV) events
  • Evaluate the efficacy of nucresiran compared to placebo on additional assessments of CV events and/or death
  • Evaluate the efficacy of nucresiran compared to placebo on patient-reported health status and health-related quality of life
Triumph-5

Status:
Follow up

Summary:
A Study of Retatrutide (LY3437943) Compared to Tirzepatide (LY3298176) in Adults Who Have Obesity (TRIUMPH-5)

Description:
The main purpose of this study is to evaluate the efficacy and safety of retatrutide compared to tirzepatide in adults who have obesity. The study will last about 89 weeks.

Structural

Complete TAVR

Status:
Enrolling

Summary:
Staged Complete Revascularization for Coronary Artery Disease vs Medical Management Alone in Patients With AS Undergoing Transcatheter Aortic Valve Replacement (COMPLETE TAVR)

Description:
This is a randomized, comparative effectiveness study of staged complete revascularization with Percutaneous Coronary Intervention (PCI) to treat Coronary Artery Disease vs medical management alone in patients with symptomatic aortic valve stenosis undergoing elective transfemoral Transcatheter Aortic Valve Replacement (TAVR).

AMPLATZER™ PFO Occluder Post Approval Study

Status:
Follow up

Summary:
OSB Lead-AMPLATZER PFO Occluder New Enrollment PAS

Description:
The purpose of this single arm, multi-center study is to confirm the safety and effectiveness of the AMPLATZER™ PFO Occluder in the post approval setting.

Envision

Status:
Enrolling

Summary:
ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation (ENVISION)

Description:
The objective of ENVISION is to evaluate the safety and effectiveness of the Navitor Transcatheter Aortic Valve Implantation (TAVI) System for treating patients with symptomatic, severe native aortic stenosis who are considered intermediate or low risk for surgical mortality.