New heart valve could offer lifeline for patients with failing artificial valves

NCT ID NCT05172973

Recruiting now Disease control Sponsor: Edwards Lifesciences Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jul 28, 2026 · Updated 3 times

Summary

This study is testing a new heart valve called the SAPIEN X4 in 200 people whose existing artificial aortic valve is failing. The valve is placed using a thin tube through an artery, avoiding open-heart surgery. The goal is to see if it is safe and effective at improving survival and quality of life.

What this could mean

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

Active substance: SAPIEN X4 transcatheter heart valve
What this could lead to: If successful, this could offer a safer, less invasive option for replacing failing bioprosthetic aortic valves, potentially improving survival and quality of life.
What could go wrong: This is an early study with only 200 participants. The valve may not work as well as hoped, and risks include death, stroke, or the need for additional procedures.

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.

aortic valve insufficiency aortic valve stenosis

As listed by the trial registrant

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

AORTIC VALVE INSUFFICIENCY AORTIC VALVE STENOSIS

Contacts and locations

Locations

Alexian Brothers Hospital Network
RECRUITING

Lisle, Illinois, 60532, United States
Allegheny General Hospital
RECRUITING

Pittsburgh, Pennsylvania, 15212, United States
Atlantic Health System Morristown
RECRUITING

Morristown, New Jersey, 07960, United States
Bay Area Structural Heart at Sutter Health
RECRUITING

San Francisco, California, 94105, United States
Brigham and Women's Hospital
RECRUITING

Boston, Massachusetts, 02115, United States
Cardiovascular Research Institute of Kansas
RECRUITING

Wichita, Kansas, 67226, United States
Carolinas Health System
RECRUITING

Charlotte, North Carolina, 28204, United States
Columbia University Medical Center / NYPH
RECRUITING

New York, New York, 10032, United States
Cornelll University New York
RECRUITING

New York, New York, 10021, United States
Emory University Atlanta
RECRUITING

Atlanta, Georgia, 30308, United States
Hamilton Health Sciences
RECRUITING

Hamilton, Ontario, L8L 2X2, Canada
Henry Ford Hospital Detroit
RECRUITING

Detroit, Michigan, 48202, United States
Hoag Memorial Hospital Presbyterian
RECRUITING

Newport Beach, California, 92663, United States
Institut Universitaire de Cardiologie et de Pneumologie de Québec- Universite Laval
RECRUITING

Québec, Quebec, G1V4G5, Canada
Kaiser San Francisco
RECRUITING

San Francisco, California, 94115, United States
Mayo Clinic
RECRUITING

Rochester, Minnesota, 55905, United States
MedStar Union Memorial Hospital
RECRUITING

Baltimore, Maryland, 21218, United States
Montefiore Medical Center
RECRUITING

New York, New York, 10458, United States
Naples Community Hospital Healthcare System
RECRUITING

Naples, Florida, 34102, United States
Northwestern University Chicago
RECRUITING

Evanston, Illinois, 60208, United States
Novant Health and Vascular Institute
RECRUITING

Charlotte, North Carolina, 28204, United States
Oklahoma Heart Institute
RECRUITING

Tulsa, Oklahoma, 74104, United States
Piedmont Heart Institute
RECRUITING

Atlanta, Georgia, 30309, United States
Robert Wood Johnson University Hospital
RECRUITING

New Brunswick, New Jersey, 08901, United States
Rochester General Hospital
RECRUITING

Rochester, New York, 14621, United States
Saint Thomas Health
RECRUITING

Nashville, Tennessee, 37205, United States
St. Paul's Hospital Vancouver
RECRUITING

Vancouver, British Columbia, V6Z1Y6, Canada
Stanford University Medical Center
RECRUITING

Stanford, California, 94305, United States
The Christ Hospital
RECRUITING

Cincinnati, Ohio, 45219, United States
The Cleveland Clinic Foundation
RECRUITING

Cleveland, Ohio, 44195, United States
The Heart Hospital Baylor Plano
RECRUITING

Plano, Texas, 75093, United States
The Valley Hospital
RECRUITING

Ridgewood, New Jersey, 07450, United States
UC Health Medical Center of the Rockies
RECRUITING

Loveland, Colorado, 80538, United States
University of Buffalo
RECRUITING

Buffalo, New York, 14203, United States
University of Texas Memorial Hermann
RECRUITING

Houston, Texas, 77030, United States
University of Washington Seattle
WITHDRAWN

Seattle, Washington, 98195, United States

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