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BIOVALVE - I / II Clincial Investigation — BIOVALVE  

Aortic Valve Stenosis Clinical Trial

Official title:
Safety and Clinical Performance of the Self-expanding Transcatheter BIOVALVE Prosthesis in Subjects With Severe Symptomatic Aortic Stenosis Suitable for Transfemoral Transcatheter Aortic Valve Implantation

Clinical Trial Summary

First-in-Human clinical investigation to evaluate the safety and clinical performance of the BIOVALVE prosthesis in subjects presenting with severe symptomatic aortic valve stenosis, which are as judged by the heart team, indicated for transfemoral transcatheter aortic valve implantation

Clinical Trial Description

In a non-randomized, prospective, multi-center clinical investigation, approximately 86 eligible subjects will be enrolled. Phase 1: BIOVALVE-I feasibility clinical investigation: Approximately 13 eligible subjects will be enrolled. Phase 2: BIOVALVE-II pilot clinical investigation: Approximately 73 eligible subjects will be enrolled. BIOVALVE-I/II subjects follow the same clinical investigation plan (CIP) in all aspects. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02249000
Study type Interventional
Source Biotronik AG
Contact
Status Completed
Phase N/A
Start date September 2014
Completion date May 2023
View Details
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