Clinical Trial

A Prospective, Multicenter, Observational Study Evaluating Safety and Effectiveness of SAPIEN 3 Transcatheter Aortic Valve Replacement for Type-0 Bicuspid Aortic Valve Stenosis Patients in China

Study acronym: ASCENT
Not Yet Recruiting
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Summary
In China, bicuspid aortic valve (BAV) represents a significantly high proportion of the transcatheter aortic valve replacement (TAVR) population. The application of TAVR in patients with BAV is challenging due to complex anatomy. To date, no prospective study has evaluated the Sapien 3 TAVR in patients with Type-0 BAV.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2026-02-27; most recent amendment 2026-05-03.
Trial Details
NCT Number NCT07450196
Lead Sponsor Chinese Academy of Medical Sciences, Fuwai Hospital
Collaborators: Edwards (Shanghai) Lifesciences Medical Supplies Co., Ltd.
Conditions Aortic Stenosis, AORTIC VALVE DISEASES
Enrollment 170 participants
Start Date 2026-04-15
Primary Completion 2028-08-31 (estimated)
Study Completion 2029-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-07