RecruitingAortic Valve InsufficiencyAortic Valve Stenosis

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

Eligible age

All ages

Accepts

All genders

Locations

19 states

Healthy volunteers

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About this study

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.

Sponsor: Edwards Lifesciences

You may qualify if…

✓ 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 been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

You may not qualify if…

✕ 1. Anatomical characteristics that would preclude safe femoral placement of the introducer sheath or safe passage of the delivery system
✕ 2. Failing valve has moderate or severe paravalvular regurgitation
✕ 3. Failing valve is unstable, rocking, or not structurally intact
✕ 4. Known severe patient-prosthesis mismatch or bioprosthetic valve with residual mean gradient \> 20 mmHg at the end of the index procedure for implantation of the original valve
✕ 5. Increased risk of THV embolization
✕ 6. Surgical or transcatheter valve in the mitral position
✕ 7. Severe mitral regurgitation (\> 3+) or ≥ moderate mitral stenosis
✕ 8. Need for mitral, tricuspid or pulmonic valve intervention within the next 12 months