An interventional study of SAPIEN X4/X4S THV in Aortic Valve Insufficiency and Aortic Valve Stenosis, sponsored by Edwards Lifesciences. Recruiting at 37 sites in 2 countries. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Edwards Lifesciences · Not applicable, Interventional, and Treatment
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.
Prospective, single arm, multicenter study
162 studies on the registry are indexed under Aortic Valve Insufficiency; 52 are open to participants now.
This study's planned enrollment of 200 is above the median of 112 across 88 interventional studies indexed under Aortic Valve Insufficiency.
Browse Aortic Valve Insufficiency studies →Edwards Lifesciences is the lead sponsor of 124 studies on the registry; 19 are open to participants now.
Of its 34 completed or terminated interventional studies of FDA-regulated products, 32 (94%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
TAVR implant in subjects with a failing aortic surgical valve.
Device: SAPIEN X4/X4S THV
TAVR implant in subjects with a failing aortic transcatheter heart valve (THV).
Device: SAPIEN X4/X4S THV
Implantation of the SAPIEN X4/X4S valve
Non-hierarchical composite of death and stroke
The number of patients that died or had a stroke
Time frame: 1 year
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.
Time frame: 30 days
KCCQ score
Time frame: 1 year
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.
Time frame: 30 days
NYHA functional class
Time frame: 1 year
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Edwards Lifesciences