RecruitingNot ApplicableNCT05172973

ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves

Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves

Sponsor

Edwards Lifesciences

Enrollment

200 participants

Start Date

Nov 22, 2023

Study Type

INTERVENTIONAL

Conditions

Aortic Valve Stenosis Aortic Valve Insufficiency

Summary

The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects who are at high or greater risk with a failing aortic bioprosthetic valve.

Eligibility

Plain Language Summary

Simplified for easier understanding

This study is looking at a procedure called transcatheter aortic valve replacement (TAVR) — specifically using the SAPIEN X4 valve — for patients whose previously implanted surgical aortic heart valves are failing. This is called valve-in-valve therapy. Researchers want to see how safe and effective it is over time. You may be eligible if: - Your previously implanted surgical aortic bioprosthetic valve is failing (moderate or severe stenosis or insufficiency) - Your heart team has determined you are at high surgical risk for another open-heart surgery - Your heart function is not severely impaired (ejection fraction above 20%) - You have symptoms of heart failure (NYHA Class II or higher) You may NOT be eligible if: - Your failing valve has moderate-to-severe leakage around it (paravalvular regurgitation) - You have had a heart attack within the past 30 days - You have had a stroke or TIA within the past 90 days - You have severe mitral valve regurgitation or stenosis - Your life expectancy is less than 24 months - You are pregnant or breastfeeding - You have active infection or endocarditis - Your left ventricular ejection fraction is below 20% Talk to your doctor to see if this trial is right for you.

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

Locations(35)

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Bay Area Structural Heart at Sutter Health

San Francisco, California, United States

Kaiser San Francisco

San Francisco, California, United States

Stanford University Medical Center

Stanford, California, United States

UC Health Medical Center of the Rockies

Loveland, Colorado, United States

Naples Community Hospital Healthcare System

Naples, Florida, United States

Emory University Atlanta

Atlanta, Georgia, United States

Piedmont Heart Institute

Atlanta, Georgia, United States

Northwestern University Chicago

Evanston, Illinois, United States

Alexian Brothers Hospital Network

Lisle, Illinois, 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

Detroit, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Atlantic Health System Morristown

Morristown, New Jersey, United States

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States

The Valley Hospital

Ridgewood, New Jersey, United States

University of Buffalo

Buffalo, New York, United States

Cornelll University New York

New York, New York, United States

Columbia University Medical Center / NYPH

New York, New York, United States

Rochester General Hospital

Rochester, New York, United States

Carolinas Health System

Charlotte, North Carolina, United States

Novant Health and Vascular Institute

Charlotte, North Carolina, United States

The Christ Hospital

Cincinnati, Ohio, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Oklahoma Heart Institute

Tulsa, Oklahoma, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Saint Thomas Health

Nashville, Tennessee, United States

University of Texas Memorial Hermann

Houston, Texas, United States

The Heart Hospital Baylor Plano

Plano, Texas, United States

University of Washington Seattle

Seattle, Washington, United States

St. Paul's Hospital Vancouver

Vancouver, British Columbia, Canada

Hamilton Health Sciences

Hamilton, Ontario, Canada

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

Québec, Canada

View Full Details on ClinicalTrials.gov

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NCT05172973

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