Edwards SAPIEN X4 Valve for Failing Aortic Valves

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

Recruiting N/A Interventional Study
Aortic Valve Insufficiency Aortic Valve Stenosis
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
200 (estimated)
Sponsor
Edwards Lifesciences · Industry
Who this trial is looking for

This trial is looking for people with a failing aortic valve who may not be able to have regular surgery. Participants will be treated with a special heart valve to see how safe and effective it is.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have a failing bioprosthetic aortic valve.
  • I have moderate or severe heart symptoms.
  • My heart team thinks I am at high risk for surgery.
  • I agree to participate and have given written consent.

You may not be able to join if

  • I have a valve that is unstable or damaged.
  • I have severe issues with nearby heart valves.
  • I have had a heart attack in the past 30 days.
  • I have an infection or serious heart problems.
  • I am pregnant or nursing.
  • I have kidney problems.
  • My body mass index is over 50.
  • I refuse blood products.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Failing aortic bioprosthetic valve demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency 2. Bioprosthetic valve size suitable for SAPIEN X4 THV 3. NYHA functional class ≥ II 4. Heart Team agrees the subject is at high or greater surgical risk 5. The subject has be…
Contacts

Edwards THV Clinical Affairs

949-250-2500

THV_CT.gov@Edwards.com

CONTACT