The purpose of this registry is to retrospectively and prospectively obtain clinical data in consecutively treated patients, in order to demonstrate that the commercially available Edwards SAPIEN Valve with the RF3 delivery system is a safe and effective treatment for patients with pulmonary regurgitation or stenosis.
Consecutive patient data should be collected at discharge, 6 months, 12 months and 2-5 years post-implant.
Study Type
OBSERVATIONAL
Enrollment
127
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, Belgium
Herz und Diabeteszentrum NRW
Bad Oeynhausen, Germany
German Heart Institute Berlin
Safety
Procedure/Device Success and Freedom from device or procedure related death
Time frame: 6 months
Safety and Effectiveness
Freedom from device or procedure related SAE and functional improvement
Time frame: 6 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Berlin, Germany
Deutsches Herzzentrum München
München, Germany
Universitätsklinikum Münster
Münster, Germany
Mater Misericordiae University Hospital
Dublin, Ireland
Schneider Children's Medical Center of Israel
Petach Tikvah, Israel
Ospedale Bambino Gesù
Rome, Italy
Policlinico San Donato
San Donato Milanese, Italy
The Cardinal Stefan Wyszyński Institute of Cardiology
Warsaw, Poland
...and 6 more locations