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Transcatheter Valve

Transcatheter Mitral Valve Replacement for Mitral Valve Disease

N/A

Waitlist Available

Led By Mayra Guerrero, MD

Research Sponsored by Edwards Lifesciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Surgical bioprosthetic valve with a true internal diameter (True ID) of 16.5 mm to 28.5 mm.

Failing surgically implanted bioprosthetic valve in the mitral position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.

Must not have

Severe right ventricle (RV) dysfunction.

Surgical or transcatheter aortic valve placed so that extension into left ventricular outflow tract (LVOT) that may impinge on the mitral implant.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new heart valve to see if it is safe and effective in patients who have a failing mitral valve.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include risks associated with heart procedures such as bleeding, blood vessel complications, irregular heartbeat requiring a pacemaker, stroke, infection around the valve (endocarditis), or even death.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My heart valve replacement is not working properly.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My right heart chamber is not working properly.

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

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I have severe leaking or narrowing in one of my heart valves.

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I have a serious heart artery problem that hasn't been treated yet.

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I have a thickened heart muscle that obstructs blood flow.

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I refuse to receive blood products.

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I haven't needed heart or lung support machines in the last 30 days.

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I have severe lung disease or need home oxygen.

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I have severe high blood pressure in my lungs.

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I am scheduled for a procedure to correct atrial fibrillation.

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I have low white blood cells, anemia, low platelets, bleeding disorders, or clotting issues.

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I cannot take blood thinners during or after my valve implant surgery.

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My kidney function is very low or I am on dialysis.

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My body's structure allows safe access for medical procedures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety and Effectiveness - Composite of All-cause Mortality and Stroke

Secondary study objectives

Kansas City Cardiomyopathy Questionnaire (KCCQ) - Change From Baseline

Mitral Regurgitation - Change From Baseline

New York Heart Association (NYHA) Functional Class - Change From Baseline

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Failing mitral transcatheter valveExperimental Treatment1 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.

0 / 16Eligibility criteria met