RecruitingNot ApplicableNCT05172960

ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve

Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve

Sponsor

Edwards Lifesciences

Enrollment

1,234 participants

Start Date

Jun 20, 2022

Study Type

INTERVENTIONAL

Conditions

Aortic Stenosis, Severe

Summary

The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS).

Eligibility

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called SAPIEN X4 THV and a medical device called SAPIEN X4S for people with aortic stenosis, severe. The study is currently recruiting participants at 65 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESAPIEN X4 THV

Implantation of the SAPIEN X4 valve

DEVICESAPIEN X4S

Implantation of the SAPIEN X4S valve

Locations(65)

Scripps Memorial Hospital La Jolla

La Jolla, California, United States

Kaiser Los Angeles

Los Angeles, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

UC Davis Medical Center Sacramento

Sacramento, California, United States

Bay Area Structural Heart at Sutter Health

San Francisco, California, United States

Kaiser San Francisco Medical Center

San Francisco, California, United States

Stanford University

Stanford, California, United States

UC Health Northern Colorado (Medical Center of the Rockies)

Loveland, Colorado, United States

Hartford Hospital

Hartford, Connecticut, United States

Naples Community Hospital Healthcare System

North Naples, Florida, United States

Piedmont Heart Institute

Atlanta, Georgia, United States

Emory University Atlanta

Atlanta, Georgia, United States

Rush University Medical Center Chicago

Chicago, Illinois, United States

Alexian Brothers Hospital Network

Elk Grove Village, Illinois, United States

NorthShore University HealthSystem Research Institute Evanston

Evanston, Illinois, United States

Northwestern University Chicago

Evanston, Illinois, United States

Silver Cross Hospital

New Lenox, Illinois, United States

St. Vincent Medical Group, Inc./ St. Vincent Heart Center of Indiana, LLC

Carmel, Indiana, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Cardiovascular Research Institute of Kansas

Wichita, Kansas, United States

Medstar Union Memorial Hospital

Baltimore, Maryland, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Henry Ford Hospital

Detroit, Michigan, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

CentraCare Heart and Vascular Center

Saint Cloud, Minnesota, United States

Saint Luke's Hospital

Kansas City, Missouri, United States

Washington University - Barnes-Jewish Hospital Saint Louis

St Louis, Missouri, United States

St. Patrick Hospital

Missoula, Montana, United States

Dartmouth-Hitchcock Medical Center, Hanover

Lebanon, New Hampshire, United States

Atlantic Health System Morristown

Morristown, New Jersey, United States

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

The Valley Hospital

Ridgewood, New Jersey, United States

University at Buffalo - Kaleida Health

Buffalo, New York, United States

Cornell Medical Center

New York, New York, United States

Columbia University Medical Center/NYPH

New York, New York, United States

Montefiore Medical Center

New York, New York, United States

Carolinas Health System

Charlotte, North Carolina, United States

Novant Health and Heart Vascular Institute

Charlotte, North Carolina, United States

The Christ Hospital

Cincinnati, Ohio, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Oklahoma Cardiovascular Research Group Oklahoma City

Oklahoma City, Oklahoma, United States

Oklahoma Heart Institute

Tulsa, Oklahoma, United States

Kaiser Portland

Clackamas, Oregon, United States

Providence Heart & Vascular Institute Portland

Portland, Oregon, United States

Pinnacle Health Harrisburg

Harrisburg, Pennsylvania, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Methodist Le Bonheur Healthcare

Germantown, Tennessee, United States

Centennial Medical Center

Nashville, Tennessee, United States

Saint Thomas Health

Nashville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Baylor Heart and Vascular Hospital

Dallas, Texas, United States

Medical City Dallas Hospital

Dallas, Texas, United States

HCA Houston Healthcare Medical Center

Houston, Texas, United States

University of Texas Memorial Hermann

Houston, Texas, United States

The Heart Hospital Baylor Plano

Plano, Texas, United States

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

University of Washington Seattle

Seattle, Washington, United States

St. Andrews War Memorial Hospital

Spring Hill, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

The Royal Melbourne Hospital

Parkville, Australia

St. Paul's Hospital System

Vancouver, British Columbia, Canada

Hamilton Health Services

Hamilton, Ontario, Canada

Institut Universitaire de Cardiologie et de Pneumologie de Quebec- Universite Laval

Québec, Quebec, Canada

Christchurch Hospital

Christchurch, New Zealand

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05172960

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