Clinical Trial: Safety and Clinical Performance of the Next-Generation SAFESYNC Transcatheter Heart Valve in Patients With Severe Aortic Stenosis

U.S., Sept. 9 -- ClinicalTrials.gov registry received information related to the study (NCT07806409) titled 'Safety and Clinical Performance of the Next-Generation SAFESYNC Transcatheter Heart Valve in Patients With Severe Aortic Stenosis' on Aug. 19.

Brief Summary: The objective of this pivotal, prospective, multicenter, single-arm clinical trial is to evaluate the safety and clinical performance of the Next-Generation INOVARE(R) SAFESYNC Bioprosthetic Heart Valve, implanted via a transcatheter approach, in patients with severe aortic stenosis, an indication for TAVI, and intermediate or higher surgical risk. The study will enroll 40 participants.

Study Start Date: Nov., 2026

Study Type: INTERVENTIONAL

Condition: Aortic Stenosis Senil...