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NCT05172960 · ClinicalTrials.gov registry record · NA
ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve
A NA study of Aortic Stenosis, Severe, sponsored by Edwards Lifesciences.
- Active
- Registry status
- NA
- Development phase
- 915
- Enrollment target
- 20
- Study locations
NCT05172960: Active NA study of Aortic Stenosis, Severe, sponsored by Edwards Lifesciences.
NCT05172960 is a NA study of Aortic Stenosis, Severe that is active but no longer recruiting, run by Edwards Lifesciences. The registered enrollment target is 915 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (35% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05172960, a NA study of Aortic Stenosis, Severe, is active but no longer recruiting, sponsored by Edwards Lifesciences.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 915 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS).
Primary Outcome
The number of patients that died or had a stroke
Conditions Studied
Interventions
- DEVICE SAPIEN X4 THV
Study Locations (20)
California
- Scripps Memorial Hospital La Jolla - La Jolla
- Kaiser Los Angeles - Los Angeles
- Cedars-Sinai Medical Center - Los Angeles
- Hoag Memorial Hospital Presbyterian - Newport Beach
- UC Davis Medical Center Sacramento - Sacramento
- Bay Area Structural Heart at Sutter Health - San Francisco
- Kaiser San Francisco Medical Center - San Francisco
- Stanford University - Stanford
Illinois
- Rush University Medical Center Chicago - Chicago
- Alexian Brothers Hospital Network - Elk Grove Village
- NorthShore University HealthSystem Research Institute Evanston - Evanston
- Northwestern University Chicago - Evanston
- Silver Cross Hospital - New Lenox
Georgia
- Piedmont Heart Institute - Atlanta
- Emory University Atlanta - Atlanta
Colorado
- UC Health Northern Colorado (Medical Center of the Rockies) - Loveland
Connecticut
- Hartford Hospital - Hartford
Florida
- Naples Community Hospital Healthcare System - North Naples
Indiana
- St. Vincent Medical Group, Inc./ St. Vincent Heart Center of Indiana, LLC - Carmel
Kansas
- University of Kansas Medical Center - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 915 participants |
| Start Date | 2022-06-20 |
| Est. Completion | 2034-12 |
| Phase | NA |
What the registry record for NCT05172960 still lists
NCT05172960 is an interventional study that assigns participants to a tested intervention. The registered 915 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (35% lower).
The record links to 1 condition, with Aortic Stenosis, Severe appearing as the primary indexed condition, and to 1 intervention - of which SAPIEN X4 THV is the first listed.
NCT05172960 names 20 study sites across 8 states, led by California, Illinois, Georgia.
Frequently Asked Questions
What is clinical trial NCT05172960 about?
NCT05172960 is a clinical study titled "ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve". The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS).
What is the current status of trial NCT05172960?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 915 participants. The study started on 2022-06-20. Estimated completion is 2034-12.
What conditions does trial NCT05172960 study?
This clinical trial studies the following conditions: Aortic Stenosis, Severe.
What interventions are being tested in trial NCT05172960?
The interventions under investigation include: SAPIEN X4 THV (DEVICE).
Who is sponsoring clinical trial NCT05172960?
This trial is sponsored by Edwards Lifesciences, which has 57 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05172960 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05172960's enrollment target sits among peer trials
915 124th of 2000 higher than 1,877 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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