RECRUITINGOBSERVATIONAL
Avalus European Registry - an Observational Study to Evaluate Safety and Efficacy in a Real World Population
About This Trial
This is a prospective, observational, single-arm, multi-center registry of patients undergoing bioprosthetic aortic valve replacement with the Avalus valve. This prospective registry aims to examine the outcome and performance of surgical aortic valve replacement with the Avalus pericardial bioprosthesis.
Who May Be Eligible (Plain English)
Who May Qualify:
- Clinical indication for replacement of the native or prosthetic aortic valve with a bioprosthesis
- Age \>= 18 years
- Patient has been adequately informed of risks and requirements of the registry (which are actually limited since the prosthesis is in full commercial use and only data registration is performed) and is able to provide willing to sign a consent form for participation in the clinical registry.
Who Should NOT Join This Trial:
- Patient requires salvage surgery (according to EuroSCORE II definitions: "patients requiring cardiopulmonary resuscitation (external cardiac massage) en route to the operating theatre or prior to induction of anaesthesia. This does not include cardiopulmonary resuscitation following induction of anaesthesia")
- Not been able to provide willing to sign a consent form
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Clinical indication for replacement of the native or prosthetic aortic valve with a bioprosthesis
* Age \>= 18 years
* Patient has been adequately informed of risks and requirements of the registry (which are actually limited since the prosthesis is in full commercial use and only data registration is performed) and is able to provide informed consent for participation in the clinical registry.
Exclusion Criteria:
* Patient requires salvage surgery (according to EuroSCORE II definitions: "patients requiring cardiopulmonary resuscitation (external cardiac massage) en route to the operating theatre or prior to induction of anaesthesia. This does not include cardiopulmonary resuscitation following induction of anaesthesia")
* Not been able to provide informed consent
Locations (19)
UZ Leuven
Leuven, Vlaams-Brabant, Belgium
UCL St Luc
Brussels, Belgium
ZOL
Genk, Belgium
AZ Maria Middelares
Ghent, Belgium
UZ Gent
Ghent, Belgium
Rigshospitalet
Copenhagen, Denmark
Kuopio University Hospital
Kuopio, Finland
CHU Nantes
Nantes, France
Schüchtermann-Klinik
Bad Rothenfelde, Germany
Universität Herzzentrum
Hamburg, Germany
Osp. S.Orsola Malpighi
Bologna, Italy
Fondazione Poliambulanza
Brescia, Italy
Villa Maria Cecilia
Cotignola, Italy
Policlinico San Donato S.P.A
Milan, Italy
European Hospital
Roma, Italy
A. Sanitaria O. Ordine Mauriziano
Torino, Italy
UMC Maastricht
Maastricht, Netherlands
Hospital Rambla
Santa Cruz de Tenerife, Spain
Hospital Clinico De Valladolid
Valladolid, Spain