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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 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.

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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.

Conditions Studied

Aortic Valve Stenosis Aortic Valve Insufficiency

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

FieldValue
Enrollment Target 200 participants
Start Date 2023-11-22
Est. Completion 2036-02
Phase NA

Sponsor

Edwards Lifesciences

57 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05172973

The ClinicalTrials.gov registry entry for NCT05172973 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,037-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (81% lower). The listed sponsor is Edwards Lifesciences, which has 57 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.