Clinical Trial

ArcFlex Sheath in TAVR Trial

Study acronym: Arc-FIT
Not Yet Recruiting
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Summary
TAVR is a crucial treatment method for aortic valve diseases. The requirements for the device to cross the aortic arch and for the bioprosthetic valve to be coaxial are quite high, and they are key steps for the success of the surgery. Investigators' aim is to evaluate the safety and effectiveness of a variable-bend sheath for the TAVR procedure.
Trial Details
NCT Number NCT07320274
Lead Sponsor Sun Yat-sen University
Conditions Valve Disease, Aortic
Enrollment 180 participants
Start Date 2026-03-01
Primary Completion 2028-12-30 (estimated)
Study Completion 2030-03-30 (estimated)
Updated on ClinicalTrials.gov 2026-01-06