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

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2026
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.
Epistemonikos ID: 15842aba145ec4acfe719c5d23ce8d2ba7a84354
First added on: Sep 09, 2026