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

Study acronym: SAFESYNC NG
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07806409
Lead Sponsor Braile Biomedica Ind. Com. e Repr. Ltda.
Conditions
(from sponsor)		 Aortic Stenosis Senile, Aortic Stenosis Symptomatic, Aortic Stenosis
Related terms Aortic Valve Stenosis
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov