ClinicalTrials.gov record
Active, not recruiting Not applicable Interventional

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

ClinicalTrials.gov ID: NCT05172960

Public ClinicalTrials.gov record NCT05172960. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Apr 22, 2026, 6:13 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Study identification

NCT ID
NCT05172960
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
Edwards Lifesciences
Industry
Enrollment
915 participants

Conditions and interventions

Interventions

  • SAPIEN X4 THV Device

Device

Eligibility (public fields only)

Age range
Not listed
Sex
All
Healthy volunteers
Not listed

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 19, 2022
Primary completion
Jul 21, 2025
Completion
Nov 30, 2034
Last update posted
Aug 13, 2025

2022 – 2034

United States locations

U.S. sites
58
U.S. states
26
U.S. cities
47
Facility City State ZIP Site status
Scripps Memorial Hospital La Jolla La Jolla California 92037
Kaiser Los Angeles Los Angeles California 90027
Cedars-Sinai Medical Center Los Angeles California 90048
Hoag Memorial Hospital Presbyterian Newport Beach California 92663
UC Davis Medical Center Sacramento Sacramento California 95817
Bay Area Structural Heart at Sutter Health San Francisco California 94109
Kaiser San Francisco Medical Center San Francisco California 94115
Stanford University Stanford California 94305
UC Health Northern Colorado (Medical Center of the Rockies) Loveland Colorado 80538
Hartford Hospital Hartford Connecticut 06102
Naples Community Hospital Healthcare System North Naples Florida 34102
Piedmont Heart Institute Atlanta Georgia 30309
Emory University Atlanta Atlanta Georgia 30322
Rush University Medical Center Chicago Chicago Illinois 60612
Alexian Brothers Hospital Network Elk Grove Village Illinois 60007
NorthShore University HealthSystem Research Institute Evanston Evanston Illinois 60201
Northwestern University Chicago Evanston Illinois 60611
Silver Cross Hospital New Lenox Illinois 60541
St. Vincent Medical Group, Inc./ St. Vincent Heart Center of Indiana, LLC Carmel Indiana 46290
University of Kansas Medical Center Kansas City Kansas 66160
Cardiovascular Research Institute of Kansas Wichita Kansas 67226
Medstar Union Memorial Hospital Baltimore Maryland 21218
Brigham and Women's Hospital Boston Massachusetts 02115
Henry Ford Hospital Detroit Michigan 48202
Mayo Clinic Rochester Rochester Minnesota 55905
CentraCare Heart and Vascular Center Saint Cloud Minnesota 56303
Saint Luke's Hospital Kansas City Missouri 64111
Washington University - Barnes-Jewish Hospital Saint Louis St Louis Missouri 63110
St. Patrick Hospital Missoula Montana 59802
Dartmouth-Hitchcock Medical Center, Hanover Lebanon New Hampshire 03756
Atlantic Health System Morristown Morristown New Jersey 07960
Rutgers Robert Wood Johnson Medical School New Brunswick New Jersey 08901
The Valley Hospital Ridgewood New Jersey 07450
University at Buffalo - Kaleida Health Buffalo New York 14203
Cornell Medical Center New York New York 10021
Columbia University Medical Center/NYPH New York New York 10032
Montefiore Medical Center New York New York 10458
Carolinas Health System Charlotte North Carolina 28203
Novant Health and Heart Vascular Institute Charlotte North Carolina 28204
The Christ Hospital Cincinnati Ohio 45219
The Cleveland Clinic Foundation Cleveland Ohio 44195
Oklahoma Cardiovascular Research Group Oklahoma City Oklahoma City Oklahoma 73120
Oklahoma Heart Institute Tulsa Oklahoma 74104
Kaiser Portland Clackamas Oregon 97015
Providence Heart & Vascular Institute Portland Portland Oregon 97225
Pinnacle Health Harrisburg Harrisburg Pennsylvania 17101
Allegheny General Hospital Pittsburgh Pennsylvania 15212
Methodist Le Bonheur Healthcare Germantown Tennessee 38138
Centennial Medical Center Nashville Tennessee 37203
Saint Thomas Health Nashville Tennessee 37205
Vanderbilt University Medical Center Nashville Tennessee 37232
Baylor Heart and Vascular Hospital Dallas Texas 75226
Medical City Dallas Hospital Dallas Texas 75230
HCA Houston Healthcare Medical Center Houston Texas 77004
University of Texas Memorial Hermann Houston Texas 77030
The Heart Hospital Baylor Plano Plano Texas 75093
Sentara Norfolk General Hospital Norfolk Virginia 23507
University of Washington Seattle Seattle Washington 98195

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05172960, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 13, 2025 · Synced Apr 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05172960 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →