RecruitingNCT05172960

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

Edwards LifesciencesMultiple US sitesView on ClinicalTrials.gov

AI Description

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).

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Who can join
child, adult, older adult
Participants
1234
Expected completion
2037-01
Funded by
industry

Conditions studied

Aortic Stenosis, Severe

What is being tested

  • DEVICE: SAPIEN X4 THV
  • DEVICE: SAPIEN X4S

What it measures

  • Non-hierarchical composite of death and stroke, The number of patients that died or had a stroke, 1 year

Centers Participating

These centers are participating in this study. Reach out to them directly to learn more.

Allegheny General Hospital

Pittsburgh, PA

Ascension Alexian Brothers Medical Center

Elk Grove Village, IL

Ascension Saint Thomas Hospital

Nashville, TN

Ascension St. Vincent Heart Center

Carmel, IN

Ascension Via Christi (Wichita)

Wichita, KS

Atrium Health Carolinas Medical Center

Charlotte, NC

Barnes-Jewish Hospital

Saint Louis, MO

Baylor Scott & White The Heart Hospital – Dallas

Dallas, TX

Baylor Scott & White The Heart Hospital – Plano

Plano, TX

Brigham and Women's Hospital

Boston, MA

California Pacific Medical Center (Van Ness Campus)

San Francisco, CA

Cedars-Sinai Medical Center

Los Angeles, CA

CentraCare – St. Cloud Hospital

Saint Cloud, MN

Cleveland Clinic

Cleveland, OH

Emory University Hospital

Atlanta, GA

Endeavor Health Evanston Hospital

Evanston, IL

Hartford Hospital

Hartford, CT

HCA Houston Healthcare Medical Center

Houston, TX

Henry Ford Health (Detroit)

Detroit, MI

Hillcrest Medical Center

Tulsa, OK

Hoag Hospital (Newport Beach)

Newport Beach, CA

Kaiser Permanente Los Angeles Medical Center

Los Angeles, CA

Kaiser Permanente San Francisco Medical Center

San Francisco, CA

Kaleida Health

Buffalo, NY

Mayo Clinic (Rochester, Minnesota)

Rochester, MN

Medical City Heart Hospital (Dallas)

Dallas, TX

MedStar Union Memorial Hospital

Baltimore, MD

Memorial Hermann-Texas Medical Center

Houston, TX

Montefiore Einstein Hospital (Moses Campus)

Bronx, NY

Morristown Medical Center

Morristown, NJ

Naples Comprehensive Health (NCH)

Naples, FL

NewYork-Presbyterian Hospital

New York, NY

Northwestern Memorial Hospital

Chicago, IL

Novant Health Presbyterian Medical Center

Charlotte, NC

Oklahoma Heart Hospital (Oklahoma City)

Oklahoma City, OK

Piedmont Atlanta Hospital

Atlanta, GA

Providence St. Patrick Hospital

Missoula, MT

Providence St. Vincent Medical Center

Portland, OR

Robert Wood Johnson University Hospital

New Brunswick, NJ

Rush University Medical Center

Chicago, IL

Saint Luke’s Hospital of Kansas City

Kansas City, MO

Scripps Memorial Hospital La Jolla

La Jolla, CA

Sentara Norfolk General Hospital

Norfolk, VA

Silver Cross Hospital

New Lenox, IL

Stanford Health Care

Stanford, CA

The Christ Hospital

Cincinnati, OH

The University of Kansas Health System

Kansas City, KS

The Valley Hospital

Paramus, NJ

TriStar Centennial Medical Center

Nashville, TN

UC Davis Medical Center

Sacramento, CA

UCHealth Medical Center of the Rockies

Loveland, CO

University of Washington Medical Center

Seattle, WA

UPMC Harrisburg

Harrisburg, PA

Vanderbilt University Medical Center

Nashville, TN

Data Sources and Methodology

Registry entry updated 2026-09-03

Deciding whether to join a study is your choice, and you can ask a study team questions before you decide anything.

If you would rather we did it with you, call us on (656) 206-4686.