Heart & Vascular Clinical Trials

Explore our current clinical trials for heart & vascular:

[Updated: 9/18/24]

Electrophysiology

Librexia – AF

Status:
Enrolling

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.

General Cardiology

Amgen OCEAN(A)

Status:
Follow-up

Summary:
Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction (OCEAN(a)) – Outcomes Trial

Description:
The primary objective of this study is to compare the effect of treatment with olpasiran, to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants with atherosclerotic cardiovascular disease (ASCVD) and elevated Lipoprotein(a).

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).

ALNYLAM KARDIA 3

Status:
Enrolling

Summary:
Study of Zilebesiran used as add on therapy with HTN

Description:
A randomized, double-blind, placebo controlled, multicenter study to evaluate the efficacy and safety of zilebesiran used as add on therapy in adult patients with High CV risk and HTN not adequately controlled by SOC meds.

Heart Failure

ALN-TTRS02-003

Status:
Follow-up

Summary:
HELIOS-B: A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy

Description:
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of Vutrisiran in patients with Transthyretin Amyloidosis with Cardiomyopathy (ATTR Amyloidosis with Cardiomyopathy).

DAPA ACT HF

Status:
Enrolling

Summary:
Dapagliflozin and Effect on Cardiovascular Events in Acute Heart Failure -Thrombolysis in Myocardial Infarction 68

Description:
This is a multicenter, randomized, double‐blind, parallel group, placebo‐controlled trial to evaluate the effect of in‐hospital initiation of Dapagliflozin on clinical outcomes in patients with Heart Failure with reduced Ejection Fraction who have been stabilized during hospitalization for acute Heart Failure.

LUX-Dx Trends

Status:
Enrolling

Summary:
Study to Evaluate Diagnostics Sensors in Heart Failure Patients Receiving Boston Scientific’s Investigational ICM System

Description:
The primary objective of this study is to collect physiological measurement data and heart failure event data that will be used to design and develop new diagnostic features for the insertable cardiac monitor (ICM) systems.  This study will not have pre-defined statistical endpoints. To support the primary objective, diagnostic sensor data will be compared to reference clinical testing data and heart failure decompensation events.

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.

Interventional Cardiology

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).

ECLIPSE Study

Status:
Follow-up

Summary:
Evaluation of Treatment Strategies for Severe CaLcIfic Coronary Arteries: Orbital Atherectomy vs. Conventional Angioplasty Technique Prior to Implantation of Drug-Eluting StEnts

Description:
This trial will evaluate Orbital Atherectomy compared to conventional balloon angioplasty technique for the treatment of severely calcified lesions prior to implantation of drug-eluting stents (DES).

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.

AMPLATZER™ PFO Occluder Post Approval Study

Status:
Enrolling

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.

Define ChiL

Status:
Enrolling

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:
Enrolling

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.

AMIHOTT III

Status:
Enrolling

Description:
A multi-center randomized post-approval evaluation of the delivery of intracoronary hyperoxemic supersaturated oxygen therapy for 60 minutes in anterior acute myocardial infarction patients with successful reperfusion (via PCI) ≤ six hours after symptom onset compared to standard therapy.

Structural

Discordance TAVR

Status:
Enrolling

Description:
Standardized Invasive Hemodynamics for Monitoring Acute and Long Term Valve Performance in Patients with Elevated Gradients Post Transcatheter Aortic Valve Replacement