New heart valve could save lives without Open-Heart surgery

NCT ID NCT05172960

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

First seen Jun 25, 2026 · Last updated Aug 12, 2026 · Updated 5 times

Summary

This trial is testing a new heart valve called SAPIEN X4/X4S in over 1,200 people with severe aortic stenosis, a condition where the heart's aortic valve narrows. The valve is inserted through a catheter, avoiding open-heart surgery. Researchers are measuring how many patients die or have a stroke, and whether patients feel better and can do more activities.

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/X4S transcatheter heart valve
What this could lead to: If successful, this could provide a safer, less invasive treatment option for people with severe aortic stenosis, potentially reducing death and stroke risks.
What could go wrong: This is an early-stage device trial without a control group, so results may not prove superiority over existing valves. Risks include stroke, death, and valve complications.

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 stenosis

As listed by the trial registrant

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

AORTIC STENOSIS, SEVERE

Contacts and locations

Locations

Alexian Brothers Hospital Network
RECRUITING

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

Pittsburgh, Pennsylvania, 15212, United States
Ascension Via Christi St. Francis (Cardiovascular Research Institute of Kansas)
RECRUITING

Wichita, Kansas, 67226, United States
Atlantic Health System Morristown
RECRUITING

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

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

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

Boston, Massachusetts, 02115, United States
Carolinas Health System
ACTIVE_NOT_RECRUITING

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

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

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

Saint Cloud, Minnesota, 56303, United States
Christchurch Hospital
ACTIVE_NOT_RECRUITING

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

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

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

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

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

Houston, Texas, 77004, United States
Hamilton Health Services
ACTIVE_NOT_RECRUITING

Hamilton, Ontario, L8L 2X2, Canada
Hartford Hospital
ACTIVE_NOT_RECRUITING

Hartford, Connecticut, 06102, United States
Henry Ford Hospital
ACTIVE_NOT_RECRUITING

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

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

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

Los Angeles, California, 90027, United States
Kaiser Portland
RECRUITING

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

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

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

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

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

Germantown, Tennessee, 38138, United States
Montefiore Medical Center
ACTIVE_NOT_RECRUITING

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

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

Evanston, Illinois, 60201, United States
Northwestern University Chicago
ACTIVE_NOT_RECRUITING

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

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

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

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

Atlanta, Georgia, 30309, United States
Pinnacle Health Harrisburg
COMPLETED

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

Portland, Oregon, 97225, United States
Royal Adelaide Hospital
ACTIVE_NOT_RECRUITING

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

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

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

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

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

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

Norfolk, Virginia, 23507, United States
Silver Cross Hospital
RECRUITING

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

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

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

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

Carmel, Indiana, 46290, United States
Stanford University
ACTIVE_NOT_RECRUITING

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

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

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

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

Parkville, 3050, Australia
The Valley Hospital
ACTIVE_NOT_RECRUITING

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

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

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

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

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

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

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

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

St Louis, Missouri, 63110, United States

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