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

NCT05172960

This study is recruiting at 31 US sites in 18 states, according to its ClinicalTrials.gov record last updated .

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).

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • Aortic Stenosis, Severe

Eligibility basics and study details

Study type
Interventional
Phase
Not applicable
Ages
Any age
Sex
All
Healthy volunteers
Not accepted
Sponsor
Edwards Lifesciences
Last updated on ClinicalTrials.gov
September 24, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

California · 4

  • Cedars-Sinai Medical Center · Los Angeles, CA
  • UC Davis Medical Center Sacramento · Sacramento, CA
  • Bay Area Structural Heart at Sutter Health · San Francisco, CA
  • Stanford University · Stanford, CA

Connecticut · 1

  • Hartford Hospital · Hartford, CT

Illinois · 4

  • Alexian Brothers Hospital Network · Elk Grove Village, IL
  • NorthShore University HealthSystem Research Institute Evanston · Evanston, IL
  • Northwestern University Chicago · Evanston, IL
  • Silver Cross Hospital · New Lenox, IL

Kansas · 1

  • Ascension Via Christi St. Francis (Cardiovascular Research Institute of Kansas) · Wichita, KS

Maryland · 1

  • Medstar Union Memorial Hospital · Baltimore, MD

Massachusetts · 1

  • Brigham and Women's Hospital · Boston, MA

Missouri · 1

  • Washington University - Barnes-Jewish Hospital Saint Louis · St Louis, MO

New Hampshire · 1

  • Dartmouth-Hitchcock Medical Center, Hanover · Lebanon, NH

New Jersey · 2

  • Atlantic Health System Morristown · Morristown, NJ
  • Rutgers Robert Wood Johnson Medical School · New Brunswick, NJ

New York · 3

  • University at Buffalo - Kaleida Health · Buffalo, NY
  • Columbia University Medical Center/NYPH · New York, NY
  • Cornell Medical Center · New York, NY

North Carolina · 1

  • Novant Health and Heart Vascular Institute · Charlotte, NC

Ohio · 1

  • The Christ Hospital · Cincinnati, OH

Oklahoma · 2

  • Oklahoma Cardiovascular Research Group Oklahoma City · Oklahoma City, OK
  • Oklahoma Heart Institute · Tulsa, OK

Oregon · 1

  • Kaiser Portland · Clackamas, OR

Pennsylvania · 1

  • Allegheny General Hospital · Pittsburgh, PA

Tennessee · 3

  • Centennial Medical Center · Nashville, TN
  • Saint Thomas Health · Nashville, TN
  • Vanderbilt University Medical Center · Nashville, TN

Texas · 2

  • Baylor Heart and Vascular Hospital · Dallas, TX
  • The Heart Hospital Baylor Plano · Plano, TX

Virginia · 1

  • Sentara Norfolk General Hospital · Norfolk, VA

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.