NCT02249000

BIOVALVE - I / II Clincial Investigation

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Biotronik AG · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Heart Valve Diseases
• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	BIOVALVE prosthesis	Transcatheter Aortic Valve Replacement (TAVR)

Timeline

• Start date: 2014-09-01
• Primary completion: 2018-03-01
• Completion: 2023-05-01
• First posted: 2014-09-25
• Last updated: 2024-06-11

Locations

13 sites across 4 countries: Belgium, Germany, Netherlands, Switzerland