Last updated on February 2018

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

Contact Investigators or Research Sites near you

Start Over

Stefan Verheye, MD

ZNA Middelheim
Antwerpen, Belgium
  Connect »

Michael Haude, MD

St dtische Kliniken Neuss - Lukaskrankenhaus
Neuss, Germany
  Connect »

Mohamed Abdel-Wahab, MD

Segeberger Kliniken
Bad Segeberg, Germany
  Connect »

Stephan Kische, MD

Vivantes Klinikum
Berlin, Germany
  Connect »

Volkmar Falk, MD

German Heart Center
Berlin, Germany
  Connect »

Hendrik Treede, MD

Universit tsklinikum Halle (Saale)
Halle, Germany
  Connect »

Christian Frerker, MD

Asklepios Klinik St. Georg
Hamburg, Germany
  Connect »

Ulrich Schaefer, MD

University Heart Center
Hamburg, Germany
  Connect »

Axel Linke, MD

Herzzentrum Leipzig
Leipzig, Germany
  Connect »

Hueseyin Ince, MD

Universit tsmedizin Rostock
Rostock, Germany
  Connect »

W.A.L Tonino, MD

Eindhoven, Netherlands
  Connect »

Francesco Maisano, MD

Universit tsspital Z rich
Zurich, Switzerland
  Connect »

Stephan Baldus, MD

University Heart Center
Köln, Germany
  Connect »