127
Participants
Start Date
January 31, 2011
Primary Completion Date
July 31, 2013
Study Completion Date
December 19, 2017
Transcatheter Pulmonic Valve Replacement (TPVR) (Edwards SAPIEN™ THV)
The Edwards SAPIEN™ THV is a biological heart valve manufactured with treated bovine pericardial tissue that is mounted into a balloon expandable stainless steel open cell stent. The Edwards SAPIEN™ THV is available in two sizes (23 and 26mm) and is designed for transcatheter implantation in patients with regurgitant pulmonary valved conduit with or without stenosis. This device is commercially available and is used according the current IFU.
University Hospital Leuven, Leuven
King Faisal Specialist Hospital & Research Centre, Riyadh
Prince Sultan Cardiac Centre, Riyadh
Policlinico San Donato, San Donato Milanese
Herz und Diabeteszentrum NRW, Bad Oeynhausen
Mehmet Akif Ersoy Thoracic & Cardiovascular Surgery, Istanbul
Universitätsklinikum Münster, Münster
Schneider Children's Medical Center of Israel, Petach Tikvah
Deutsches Herzzentrum München, München
German Heart Institute Berlin, Berlin
Mater Misericordiae University Hospital, Dublin
Ospedale Bambino Gesù, Rome
The Cardinal Stefan Wyszyński Institute of Cardiology, Warsaw
Royal Brompton Hospital, London
The Heart Hospital, London
Manchester Royal Infirmary, Manchester
Lead Sponsor
Edwards Lifesciences
INDUSTRY