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Clinical Trial

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
StatusNOT_YET_RECRUITING
SponsorBraile Biomedica Ind. Com. e Repr. Ltda. (INDUSTRY)
First posted
Last updated

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® 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.

Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.

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