New heart valve could save thousands from deadly narrowing

NCT ID NCT05172960

Ongoing Disease control Sponsor: Edwards Lifesciences Source: ClinicalTrials.gov ↗

First seen May 23, 2026 · Last updated May 23, 2026

Summary

This study tests a new balloon-expandable heart valve (SAPIEN X4) in 1,234 people with severe aortic stenosis, a condition where the heart's main valve narrows. The goal is to see if the valve is safe and works well. Participants receive the valve through a tube in their leg, avoiding open-heart surgery.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

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Locations

Alexian Brothers Hospital Network

Elk Grove Village, Illinois, 60007, United States
Allegheny General Hospital

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

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

San Francisco, California, 94109, United States
Baylor Heart and Vascular Hospital

Dallas, Texas, 75226, United States
Brigham and Women's Hospital

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

Wichita, Kansas, 67226, United States
Carolinas Health System

Charlotte, North Carolina, 28203, United States
Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States
Centennial Medical Center

Nashville, Tennessee, 37203, United States
CentraCare Heart and Vascular Center

Saint Cloud, Minnesota, 56303, United States
Christchurch Hospital

Christchurch, 8011, New Zealand
Columbia University Medical Center/NYPH

New York, New York, 10032, United States
Cornell Medical Center

New York, New York, 10021, United States
Dartmouth-Hitchcock Medical Center, Hanover

Lebanon, New Hampshire, 03756, United States
Emory University Atlanta

Atlanta, Georgia, 30322, United States
HCA Houston Healthcare Medical Center

Houston, Texas, 77004, United States
Hamilton Health Services

Hamilton, Ontario, L8L 2X2, Canada
Hartford Hospital

Hartford, Connecticut, 06102, United States
Henry Ford Hospital

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

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

Québec, Quebec, G1V 4G5, Canada
Kaiser Los Angeles

Los Angeles, California, 90027, United States
Kaiser Portland

Clackamas, Oregon, 97015, United States
Kaiser San Francisco Medical Center

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

Rochester, Minnesota, 55905, United States
Medical City Dallas Hospital

Dallas, Texas, 75230, United States
Medstar Union Memorial Hospital

Baltimore, Maryland, 21218, United States
Methodist Le Bonheur Healthcare

Germantown, Tennessee, 38138, United States
Montefiore Medical Center

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

North Naples, Florida, 34102, United States
NorthShore University HealthSystem Research Institute Evanston

Evanston, Illinois, 60201, United States
Northwestern University Chicago

Evanston, Illinois, 60611, United States
Novant Health and Heart Vascular Institute

Charlotte, North Carolina, 28204, United States
Oklahoma Cardiovascular Research Group Oklahoma City

Oklahoma City, Oklahoma, 73120, United States
Oklahoma Heart Institute

Tulsa, Oklahoma, 74104, United States
Piedmont Heart Institute

Atlanta, Georgia, 30309, United States
Pinnacle Health Harrisburg

Harrisburg, Pennsylvania, 17101, United States
Providence Heart & Vascular Institute Portland

Portland, Oregon, 97225, United States
Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia
Rush University Medical Center Chicago

Chicago, Illinois, 60612, United States
Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States
Saint Luke's Hospital

Kansas City, Missouri, 64111, United States
Saint Thomas Health

Nashville, Tennessee, 37205, United States
Scripps Memorial Hospital La Jolla

La Jolla, California, 92037, United States
Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States
Silver Cross Hospital

New Lenox, Illinois, 60541, United States
St. Andrews War Memorial Hospital

Spring Hill, Queensland, 4000, Australia
St. Patrick Hospital

Missoula, Montana, 59802, United States
St. Paul's Hospital System

Vancouver, British Columbia, V6E 1M7, Canada
St. Vincent Medical Group, Inc./ St. Vincent Heart Center of Indiana, LLC

Carmel, Indiana, 46290, United States
Stanford University

Stanford, California, 94305, United States
The Christ Hospital

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

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

Plano, Texas, 75093, United States
The Royal Melbourne Hospital

Parkville, 3050, Australia
The Valley Hospital

Ridgewood, New Jersey, 07450, United States
UC Davis Medical Center Sacramento

Sacramento, California, 95817, United States
UC Health Northern Colorado (Medical Center of the Rockies)

Loveland, Colorado, 80538, United States
University at Buffalo - Kaleida Health

Buffalo, New York, 14203, United States
University of Kansas Medical Center

Kansas City, Kansas, 66160, United States
University of Texas Memorial Hermann

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

Seattle, Washington, 98195, United States
Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States
Washington University - Barnes-Jewish Hospital Saint Louis

St Louis, Missouri, 63110, United States

Conditions

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AORTIC STENOSIS, SEVERE