Pulmonic Valve REplacement Multi-discIpline EMEA Registry
This trial is active, not recruiting.
|Conditions||pulmonary regurgitation, pulmonary insufficiency, pulmonary stenosis|
|Treatment||transcatheter pulmonic valve replacement (tpvr) (edwards sapien™ thv)|
|Start date||January 2011|
|End date||July 2013|
|Trial size||127 participants|
|Trial identifier||NCT01356108, 2010-11|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Leuven, Belgium||University Hospital Leuven||no longer recruiting|
|Bad Oeynhausen, Germany||Herz und Diabeteszentrum NRW||no longer recruiting|
|Berlin, Germany||German Heart Institute Berlin||no longer recruiting|
|München, Germany||Deutsches Herzzentrum München||no longer recruiting|
|Münster, Germany||Universitätsklinikum Münster||no longer recruiting|
|Dublin, Ireland||Mater Misericordiae University Hospital||no longer recruiting|
|Petach Tikvah, Israel||Schneider Children's Medical Center of Israel||no longer recruiting|
|Rome, Italy||Ospedale Bambino Gesù||no longer recruiting|
|San Donato Milanese, Italy||Policlinico San Donato||no longer recruiting|
|Warsaw, Poland||The Cardinal Stefan Wyszyński Institute of Cardiology||no longer recruiting|
|Riyadh, Saudi Arabia||King Faisal Specialist Hospital & Research Centre||no longer recruiting|
|Riyadh, Saudi Arabia||Prince Sultan Cardiac Centre||no longer recruiting|
|Istanbul, Turkey||Mehmet Akif Ersoy Thoracic & Cardiovascular Surgery||no longer recruiting|
|London, United Kingdom||Royal Brompton Hospital||no longer recruiting|
|London, United Kingdom||The Heart Hospital||no longer recruiting|
|Manchester, United Kingdom||Manchester Royal Infirmary||no longer recruiting|
time frame: 6 months
Safety and Effectiveness
time frame: 6 Months
All participants at least 19 years old.
- Symptomatic with a regurgitant or stenotic pulmonary valved conduit.
- Angiographic evidence of coronary artery compression.
- RV-PA pulmonary conduit size that is either too large or too small to accommodate the SAPIEN THV.
- Thrombus or intracardiac mass in the right atrium, right ventricle, and/or pulmonic valve.
- Severe coagulation problems and/or unable to tolerate anticoagulation/antiplatelet therapy.
- Active bacterial endocarditis or other active infections.
- Illeofemoral venous stenosis that may prevent the placement of the introducer sheath and/or central venous vascular tortuosities that may prevent advancement of the delivery system to the heart or into the pulmonary artery.
- Presence of any prosthetic valve in the tricuspid position.
- Unstable coronary artery disease-related angina.
- Placement of the SAPIEN THV in pregnant females.
|Official title||Implantation of the SAPIEN™ Transcatheter Heart Valve (THV) in the Pulmonic Position|
|Principal investigator||Peter Ewert, MD|
|Description||Consecutive patient data should be collected at discharge, 6 months, 12 months and 2-5 years post-implant.|
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