Status: Not yet recruiting
Safety and Clinical Performance of the Next-Generation SAFESYNC Transcatheter Heart Valve in Patients With Severe Aortic Stenosis
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.
Participants needed: 40
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Braile Biomedica Ind. Com. e Repr. Ltda.Updated: Sep 8, 2026
Eligibility criteria
Severe aortic valve stenosis diagnosed according to criteria established in curr... [+3]
Any condition considered a contraindication to implantation of a bioprosthetic h... [+17]