臨床試驗

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

NCT：NCT07806409 · NOT_YET_RECRUITING

NCT IDNCT07806409

狀態NOT_YET_RECRUITING

SponsorBraile Biomedica Ind. Com. e Repr. Ltda. (INDUSTRY)

First posted2026-09-08

Last updated2026-09-08

簡要摘要

The objective of this pivotal, prospective, multicenter, single-arm clinical trial is to evaluate the safety and clinical performance of the Next-Generation INOVARE® 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.

官方來源

在 ClinicalTrials.gov 上查看 →

資料來自 ClinicalTrials.gov API。最新狀態請參閱官方紀錄。