Recruiting

A new device to repair a leaky heart valve

Plain-English translation of NCT04097145 on ClinicalTrials.gov ↗ · Source last updated July 2026 · Translation generated July 2026 · How we translate trials

This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.

What is this trial?

This trial is testing the Edwards PASCAL Transcatheter Valve Repair System, a new device that repairs a leaky tricuspid valve (one of your heart's four valves) without open-heart surgery. Half of the participants will receive the device along with their regular heart medications, and half will continue with medications alone. The trial will follow both groups for up to 5 years to see if the device helps people feel better and reduces hospitalizations.

A leaky tricuspid valve can cause fatigue, shortness of breath, and repeated hospitalizations. Traditional surgery to fix this valve carries significant risk for some patients. This trial is testing whether this new, less invasive device offers a safer option for people who are too high-risk for open-heart surgery.

Do you qualify?

You likely qualify if…

you are 18 years old or older
you have severe tricuspid regurgitation (leaking) that is causing symptoms or has led to heart failure hospitalizations despite taking heart medications
you have moderate to severe heart failure symptoms or were hospitalized for heart failure in the past year
your doctor and surgical team believe you are at higher risk for complications if you had traditional valve surgery
you are willing to attend follow-up visits and comply with study procedures for up to 5 years

You likely don't qualify if…

you have heart valve anatomy that cannot be clearly seen on ultrasound or is unsuitable for the device
you have end-stage heart failure requiring advanced treatments like a left ventricular assist device or transplant
you have pacemaker or defibrillator leads that would interfere with the device or were placed in the past 90 days
you have had a stroke, blood clots, or active infections within the past 90 days, or untreated coronary artery disease
you have other severe heart valve problems, certain rare heart conditions, or planned heart surgery within the next year

What participation looks like

If you are randomly selected to receive the device, you will undergo a catheter-based procedure (similar to a heart catheterization) where doctors thread the device to your tricuspid valve without open-heart surgery. You will continue taking your regular heart medications. If you are assigned to the medication-only group, you will continue your current treatment plan. All participants will have follow-up visits at discharge, 30 days, 3 months, 6 months, and yearly for up to 5 years, where doctors will check your heart function and symptoms.

AI-generated summary from trial data · Jul 13, 2026 · Not medical advice

Trial locations(79 sites)

United States

Banner University Medical Center Phoenix, Phoenix, Arizona

Tucson Medical Center Healthcare, Tucson, Arizona

University of California, Irvine, Irvine, California

SCPMG - Kaiser San Diego, La Jolla, California

Cedars Sinai Medical Center, Los Angeles, California