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.
Failing aortic bioprosthetic valve demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency
Bioprosthetic valve size suitable for SAPIEN X4 THV
NYHA functional class ≥ II
Heart Team agrees the subject is at high or greater surgical risk
Anatomical characteristics that would preclude safe femoral placement of the introducer sheath or safe passage of the delivery system
Failing valve has moderate or severe paravalvular regurgitation
Failing valve is unstable, rocking, or not structurally intact
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
Single group
SAPIEN X4/X4S THV
DeviceImplantation of the SAPIEN X4/X4S valve
Non-hierarchical composite of death and stroke
The number of patients that died or had a stroke
Kansas City Cardiomyopathy Questionnaire (KCCQ) score
The KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. An overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
KCCQ score
New York Heart Association (NYHA) functional class
NYHA is a functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest (I) as no limitations and the highest (IV) unable to carry on any physical activity without discomfort.
NYHA functional class
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