A single-arm, non-randomized, multi-center clinical study of the Amplatzer™ Trevisio™ Intravascular Delivery System for facilitating percutaneous, transcatheter implantation of the Amplatzer™ Occluder Devices.
Study Type
OBSERVATIONAL
Enrollment
251
Amplatzer Trevisio Delivery System is used for facilitating percutaneous, transcatheter implantation of the Amplatzer PFO Occluder, ASO or Amplatzer Cribriform Occluder.
Amplatzer Trevisio Delivery System is used for facilitating percutaneous, transcatheter implantation of the Amplatzer Muscular VSD Occluder or Amplatzer Post-Infarct Muscular VSD Occluder.
CHU Trousseau
Chambray-lès-Tours, France
CHU Gabriel Montpied
Effectiveness Endpoint: Technical Success -successful deployment and release of at least one device
Time frame: 5years
Safety Endpoint : Device- or procedure-related serious adverse events through discharge or 7 days, whichever occurs first
Includes: * Cardiac perforation * Sustained atrial fibrillation requiring intervention * Device thrombus * Device erosion * Device embolization * Vascular complication requiring surgical intervention * Device- or procedure related serious adverse event leading to death
Time frame: 5years
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Clermont-Ferrand, France
Centre Médico Chirurgical Marie Lannelongue
Le Plessis-Robinson, France
CHRU Lille
Lille, France
Hopital d'adulte de la Timone
Marseille, France
CHU Hopital G. & R. Laënnec
Nantes, France
Hopital Haut Leveque
Pessac, France
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, Germany
Deutsches Herzzentrum Berlin
Berlin, Germany
Universitätsklinikum Schleswig-Holstein Campus Kiel
Kiel, Germany
...and 12 more locations