New heart valve procedure offers hope for High-Risk patients

NCT ID NCT04408430

Recruiting now Disease control Sponsor: Mayra Guerrero Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a new way to replace a damaged heart valve (the mitral valve) without open-heart surgery. It uses a special valve delivered through a thin tube (catheter) for people with severe symptoms who are not healthy enough for standard surgery. The study will enroll 210 participants and compare the new procedure to standard medical treatment.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Edwards SAPIEN 3/Ultra/RESILIA valve (a replacement heart valve delivered through a catheter)
What this could lead to: If successful, this could offer a less invasive treatment option for people with severe mitral valve disease who are too high-risk for open-heart surgery.
What could go wrong: This is an early-stage study with only 210 participants, so results may not apply to everyone. Risks include stroke, heart failure, or the valve not working as intended.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

mitral valve disorder mitral valve insufficiency mitral valve stenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

MITRAL ANNULAR CALCIFICATION MITRAL REGURGITATION MITRAL STENOSIS MITRAL VALVE DISEASE

Contacts and locations

Locations

Banner - University Medicine Cardiology Clinic
RECRUITING

Phoenix, Arizona, 85006, United States
Brigham and Women's Hospital
RECRUITING

Boston, Massachusetts, 02115, United States
Cedars-Sinai Medical Center
RECRUITING

Los Angeles, California, 90048, United States
Columbia University Medical Center/NYPH
RECRUITING

New York, New York, 10032, United States
Dignity Health Chandler Regional Medical Center
RECRUITING

Gilbert, Arizona, 85297, United States
Ignacio Chávez National Institute of Cardiology
RECRUITING

Mexico City, 14080, Mexico
Intermountain Medical Center
RECRUITING

Murray, Utah, 84107, United States
Massachusetts General Hospital
RECRUITING

Boston, Massachusetts, 02114, United States
Mayo Clinic
ACTIVE_NOT_RECRUITING

Rochester, Minnesota, 55905, United States
Medstar Washington Hospital Center
RECRUITING

Washington D.C., District of Columbia, 200100, United States
Oklahoma Heart Institute Utica Office
RECRUITING

Tulsa, Oklahoma, 74104, United States
Oregon Health & Science University
RECRUITING

Portland, Oregon, 97239, United States
Pima Heart & Vascular
RECRUITING

Tucson, Arizona, 85712, United States
Sutter Health
RECRUITING

San Francisco, California, 94109, United States
The Sentara Heart Valve and Structural Disease Center
ACTIVE_NOT_RECRUITING

Norfolk, Virginia, 23507, United States
Uchealth Heart & Vascular Clinic Harmony Campus
ACTIVE_NOT_RECRUITING

Fort Collins, Colorado, 80528, United States
University Health
RECRUITING

San Antonio, Texas, 78229, United States

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