RecruitingAortic Stenosis, Severe

ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve

Eligible age

All ages

Accepts

All genders

Locations

26 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 with symptomatic, severe, calcific aortic stenosis (AS).

Sponsor: Edwards Lifesciences

You may qualify if…

✓ 1. Severe, calcific AS
✓ 2. Native aortic annulus size suitable for SAPIEN X4 THV
✓ 3. NYHA functional class ≥ II
✓ 4. 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. Aortic valve is unicuspid, bicuspid or non-calcified
✕ 3. Pre-existing mechanical or bioprosthetic valve in any position
✕ 4. Severe aortic regurgitation (\> 3+)
✕ 5. Severe mitral regurgitation (\> 3+) or ≥ moderate mitral stenosis
✕ 6. Need for mitral, tricuspid or pulmonic valve intervention within the next 12 months
✕ 7. Left ventricular ejection fraction \< 20%
✕ 8. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation