Transcatheter Mitral Valve Replacement for Mitral Valve Disease

Recruiting at 18 trial locations

Overseen by Alan Zajarias, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Edwards Lifesciences

No Placebo Group

Trial Summary

What is the purpose of this trial?

To assess the safety and effectiveness of the SAPIEN 3 transcatheter heart valve in patients with a failing mitral bioprosthetic valve.

Research Team

Mayra Guerrero, MD

Principal Investigator

Mayo Clinic

Alan Zajarias, MD

Principal Investigator

Washington University School of Medicine

Chris S. Malaisrie, MD

Principal Investigator

Northwestern University Feinberg School of Medicine

Eligibility Criteria

The PARTNER 3 Trial is for patients with a failing mitral valve from a previous surgery, who are at intermediate risk for heart surgery. They must have moderate to severe issues with their valve and symptoms of heart failure (NYHA Class ≥ II). Patients should not have serious kidney disease, recent strokes or heart attacks, life expectancy under 2 years, or be pregnant.

Inclusion Criteria

I have a surgical heart valve that is between 16.5 mm and 28.5 mm in size.

My heart valve replacement is not working properly.

The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) / Ethics Committee (EC) of the respective clinical site.

Exclusion Criteria

My right heart chamber is not working properly.

I have a valve in my heart that might affect a new mitral implant.

After the original valve surgery, there was still a high level of pressure in the heart.

Treatment Details

Interventions

• Edwards SAPIEN 3 transcatheter valve, Model 9600TFX (Transcatheter Valve)

Trial Overview This trial tests the safety and effectiveness of the Edwards SAPIEN 3 transcatheter heart valve in patients whose previously implanted surgical bioprosthetic mitral valves are no longer working properly.

Participant Groups

Group I: Failing mitral transcatheter valve Experimental Treatment 1 Intervention

Patients with a failing bioprosthetic valve in the mitral position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN 3 transcatheter valve.

Who Is Running the Clinical Trial?

Edwards Lifesciences

Lead Sponsor

Trials

188

Recruited

67,500+

Founded

1958

Headquarters

Irvine, California, U.S.

Known For

Structural Heart Innovations

Top Products

SAPIEN Transcatheter Heart Valve, EVOQUE System, PASCAL Precision, SAPIEN M3

Todd Brinton

Edwards Lifesciences

Chief Medical Officer since 2023

MD from Stanford University

Bernard Zovighian

Edwards Lifesciences

Chief Executive Officer since 2023

MBA from INSEAD