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NCT05172973 · ClinicalTrials.gov registry record · NA
ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves
A NA study of Aortic Valve Stenosis and Aortic Valve Insufficiency, sponsored by Edwards Lifesciences.
- Recruiting
- Registry status
- NA
- Development phase
- 200
- Enrollment target
- 20
- Study locations
NCT05172973: Recruiting NA study of Aortic Valve Stenosis and Aortic Valve Insufficiency, sponsored by Edwards Lifesciences.
NCT05172973 is a NA study of Aortic Valve Stenosis and Aortic Valve Insufficiency that is actively recruiting participants, run by Edwards Lifesciences. The registered enrollment target is 200 participants, below the 1,037-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (81% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05172973, a NA study of Aortic Valve Stenosis and Aortic Valve Insufficiency, is actively recruiting participants, sponsored by Edwards Lifesciences.
- RECRUITING
- Registry status
- NA
- Development phase
- 200 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 who are at high or greater risk with a failing aortic bioprosthetic valve.
Primary Outcome
The number of patients that died or had a stroke
Conditions Studied
Interventions
- DEVICE SAPIEN X4 THV
Study Locations (20)
California
- Hoag Memorial Hospital Presbyterian - Newport Beach
- Bay Area Structural Heart at Sutter Health - San Francisco
- Kaiser San Francisco - San Francisco
- Stanford University Medical Center - Stanford
New Jersey
- Atlantic Health System Morristown - Morristown
- Robert Wood Johnson University Hospital - New Brunswick
- The Valley Hospital - Ridgewood
Georgia
- Emory University Atlanta - Atlanta
- Piedmont Heart Institute - Atlanta
Illinois
- Northwestern University Chicago - Evanston
- Alexian Brothers Hospital Network - Lisle
New York
- University of Buffalo - Buffalo
- Cornelll University New York - New York
Colorado
- UC Health Medical Center of the Rockies - Loveland
Florida
- Naples Community Hospital Healthcare System - Naples
Kansas
- Cardiovascular Research Institute of Kansas - Wichita
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2023-11-22 |
| Est. Completion | 2036-02 |
| Phase | NA |
What NCT05172973 shows while recruiting
NCT05172973 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 1,037-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (81% lower).
The record links to 2 conditions, with Aortic Valve Stenosis appearing as the primary indexed condition, and to 1 intervention - of which SAPIEN X4 THV is the first listed.
NCT05172973 names 20 study sites across 12 states, led by California, New Jersey, Georgia.
Frequently Asked Questions
What is clinical trial NCT05172973 about?
NCT05172973 is a clinical study titled "ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves". The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects who are at high or greater risk with a failing aortic bioprosthetic valve.
What is the current status of trial NCT05172973?
This trial is currently recruiting. It is a NA study. The enrollment target is 200 participants. The study started on 2023-11-22. Estimated completion is 2036-02.
What conditions does trial NCT05172973 study?
This clinical trial studies the following conditions: Aortic Valve Stenosis, Aortic Valve Insufficiency.
What interventions are being tested in trial NCT05172973?
The interventions under investigation include: SAPIEN X4 THV (DEVICE).
Who is sponsoring clinical trial NCT05172973?
This trial is sponsored by Edwards Lifesciences, which has 57 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05172973 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05172973's enrollment target sits among peer trials
200 14th of 30 higher than 15 of 30 other Aortic Valve Stenosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Aortic Valve Stenosis 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.
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