Last updated on February 2017

BIOVALVE - I / II Clincial Investigation


Brief description of study

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 Study 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.

Clinical Study Identifier: NCT02249000

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Stefan Verheye, MD

ZNA Middelheim
Antwerpen, Belgium
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Michael Haude, MD

St dtische Kliniken Neuss - Lukaskrankenhaus
Neuss, Germany
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Mohamed Abdel-Wahab, MD

Segeberger Kliniken
Bad Segeberg, Germany
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Stephan Kische, MD

Vivantes Klinikum
Berlin, Germany
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Volkmar Falk, MD

German Heart Center
Berlin, Germany
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Hendrik Treede, MD

Universit tsklinikum Halle (Saale)
Halle, Germany
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Christian Frerker, MD

Asklepios Klinik St. Georg
Hamburg, Germany
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Ulrich Schaefer, MD

University Heart Center
Hamburg, Germany
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Stephan Baldus, MD

University Heart Center
Köln, Germany
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Axel Linke, MD

Herzzentrum Leipzig
Leipzig, Germany
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Hueseyin Ince, MD

Universit tsmedizin Rostock
Rostock, Germany
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W.A.L Tonino, MD

Catharina-Ziekenhuis
Eindhoven, Netherlands
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Francesco Maisano, MD

Universit tsspital Z rich
Zurich, Switzerland
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