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

U.S., March 5 -- ClinicalTrials.gov registry received information related to the study (NCT07450196) titled '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' on Feb. 27.

Brief 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.

Study Start Date: Feb. 28

Study Type: OBSERVATIONAL

Condition: Aortic Stenosis AORTIC VALVE ...