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NOT YET RECRUITING
NCT07806409
NA

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

Sponsor: Braile Biomedica Ind. Com. e Repr. Ltda.

View on ClinicalTrials.gov

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 title: Evaluation of the Safety and Clinical Performance of the Next-Generation SAFESYNC Balloon-Expandable Transcatheter Heart Valve in Patients With Severe Aortic Stenosis: A Prospective, Multicenter, Single-Arm Pivotal Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-11

Completion Date

2032-06

Last Updated

2026-09-08

Healthy Volunteers

No

Interventions

DEVICE

INOVARE® SAFESYNC Next-Generation Bioprosthetic Heart Valve

Participants will undergo TAVI via transfemoral access using the INOVARE® SAFESYNC Next-Generation Bioprosthetic Heart Valve and the B-Delivery System.