Clinical Research Directory

A Prospective, Multi-centre, Single Arm, Pivotal Clinical Study to Determine the Safety and Effectiveness of Crea Aortic Valve for Use as a Replacement Aortic Heart Valve

Sponsor: Onecrea Medical Inc.

Summary

This is a prospective, multicenter, single-arm clinical investigation designed to evaluate the safety and performance of an investigational transcatheter aortic valve replacement system in patients with symptomatic severe native aortic valve stenosis who are considered appropriate candidates for transcatheter valve replacement. Eligible subjects will be enrolled at multiple investigational sites and followed according to the clinical investigation plan. The study will assess procedural success, device performance, and clinical safety using predefined clinical and echocardiographic outcome measures. Subjects will undergo scheduled follow-up evaluations to assess device performance, functional status, quality of life, and the occurrence of adverse clinical events over the study period.

Key Details

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