Avalus European Registry - an Observational Study to Evaluate Safety and Efficacy in a Real World Population
Status: Recruiting
Location: See all (19) locations...
Study Type: Observational
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Belgium
UCL St Luc
RECRUITING
Brussels
ZOL
RECRUITING
Genk
AZ Maria Middelares
RECRUITING
Ghent
UZ Gent
RECRUITING
Ghent
UZ Leuven
RECRUITING
Leuven
Denmark
Rigshospitalet
RECRUITING
Copenhagen
Finland
Kuopio University Hospital
RECRUITING
Kuopio
France
CHU Nantes
RECRUITING
Nantes
Germany
Schüchtermann-Klinik
RECRUITING
Bad Rothenfelde
Universität Herzzentrum
RECRUITING
Hamburg
Italy
Osp. S.Orsola Malpighi
RECRUITING
Bologna
Fondazione Poliambulanza
RECRUITING
Brescia
Villa Maria Cecilia
RECRUITING
Cotignola
Policlinico San Donato S.P.A
RECRUITING
Milan
European Hospital
RECRUITING
Roma
A. Sanitaria O. Ordine Mauriziano
RECRUITING
Torino
Netherlands
UMC Maastricht
RECRUITING
Maastricht
Spain
Hospital Rambla
RECRUITING
Santa Cruz De Tenerife
Hospital Clinico De Valladolid
RECRUITING
Valladolid
Contact Information
Primary
Bart Meuris
bart.meuris@uzleuven.be
+32 16 344260
Backup
Tom Verbelen
tom.verbelen@uzleuven.be
+32 16 344260
Time Frame
Start Date: 2020-06-10
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 1000
Related Therapeutic Areas
Sponsors
Leads: Universitaire Ziekenhuizen KU Leuven