Ensaio clínico

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

NCT: NCT07806409 · NOT_YET_RECRUITING

ID NCTNCT07806409

EstadoNOT_YET_RECRUITING

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

First posted2026-09-08

Last updated2026-09-08

Resumo breve

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.

Fonte oficial

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