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Recruiting Not applicable Interventional

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

ClinicalTrials.gov ID: NCT05172973

Public ClinicalTrials.gov record NCT05172973. 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.

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ClinicalTrials.gov public records Last synced Sep 1, 2026, 3:24 PM 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 in Failing Aortic Bioprosthetic Valves

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects who are at high or greater risk with a failing aortic bioprosthetic valve.

Study identification

NCT ID
NCT05172973
Recruitment status
Recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
Edwards Lifesciences
Industry
Enrollment
200 participants

Conditions and interventions

Interventions

Device

Eligibility (public fields only)

Age range
Not listed
Sex
All
Healthy volunteers
Healthy volunteers not accepted

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

Study timeline

Start date
Nov 21, 2023
Primary completion
Feb 28, 2029
Completion
Nov 30, 2039
Last update posted
Jul 26, 2026

2023 – 2039

United States locations

U.S. sites
33
U.S. states
19
U.S. cities
28
Facility City State ZIP Site status
Hoag Memorial Hospital Presbyterian Newport Beach California 92663 Recruiting
Bay Area Structural Heart at Sutter Health San Francisco California 94105 Recruiting
Kaiser San Francisco San Francisco California 94115 Recruiting
Stanford University Medical Center Stanford California 94305 Recruiting
UC Health Medical Center of the Rockies Loveland Colorado 80538 Recruiting
Naples Community Hospital Healthcare System Naples Florida 34102 Recruiting
Emory University Atlanta Atlanta Georgia 30308 Recruiting
Piedmont Heart Institute Atlanta Georgia 30309 Recruiting
Northwestern University Chicago Evanston Illinois 60208 Recruiting
Alexian Brothers Hospital Network Lisle Illinois 60532 Recruiting
Cardiovascular Research Institute of Kansas Wichita Kansas 67226 Recruiting
MedStar Union Memorial Hospital Baltimore Maryland 21218 Recruiting
Brigham and Women's Hospital Boston Massachusetts 02115 Recruiting
Henry Ford Hospital Detroit Detroit Michigan 48202 Recruiting
Mayo Clinic Rochester Minnesota 55905 Recruiting
Atlantic Health System Morristown Morristown New Jersey 07960 Recruiting
Robert Wood Johnson University Hospital New Brunswick New Jersey 08901 Recruiting
The Valley Hospital Ridgewood New Jersey 07450 Recruiting
University of Buffalo Buffalo New York 14203 Recruiting
Cornelll University New York New York New York 10021 Recruiting
Columbia University Medical Center / NYPH New York New York 10032 Recruiting
Montefiore Medical Center New York New York 10458 Recruiting
Rochester General Hospital Rochester New York 14621 Recruiting
Carolinas Health System Charlotte North Carolina 28204 Recruiting
Novant Health and Vascular Institute Charlotte North Carolina 28204 Recruiting
The Christ Hospital Cincinnati Ohio 45219 Recruiting
The Cleveland Clinic Foundation Cleveland Ohio 44195 Recruiting
Oklahoma Heart Institute Tulsa Oklahoma 74104 Recruiting
Allegheny General Hospital Pittsburgh Pennsylvania 15212 Recruiting
Saint Thomas Health Nashville Tennessee 37205 Recruiting
University of Texas Memorial Hermann Houston Texas 77030 Recruiting
The Heart Hospital Baylor Plano Plano Texas 75093 Recruiting
University of Washington Seattle Seattle Washington 98195 Withdrawn

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 3 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05172973, 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 Jul 26, 2026 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05172973 live on ClinicalTrials.gov.

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