Actively Recruiting
Avalus European Registry - an Observational Study to Evaluate Safety and Efficacy in a Real World Population
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-01
1000
Participants Needed
19
Research Sites
290 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Avalus European Registry - an Observational Study to Evaluate Safety and Efficacy in a Real World Population
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical indication for replacement of the native or prosthetic aortic valve with a bioprosthesis
- Age 18 years or older
- Patient has been adequately informed of risks and requirements of the registry and is able to provide informed consent for participation
You will not qualify if you...
- Patient requires salvage surgery, defined as needing cardiopulmonary resuscitation en route to the operating theatre or before anesthesia
- Unable to provide informed consent
AI-Screening
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Trial Site Locations
Total: 19 locations
1
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
2
UCL St Luc
Brussels, Belgium
Actively Recruiting
3
ZOL
Genk, Belgium
Actively Recruiting
4
AZ Maria Middelares
Ghent, Belgium
Actively Recruiting
5
UZ Gent
Ghent, Belgium
Actively Recruiting
6
Rigshospitalet
Copenhagen, Denmark
Actively Recruiting
7
Kuopio University Hospital
Kuopio, Finland
Actively Recruiting
8
CHU Nantes
Nantes, France
Actively Recruiting
9
Schüchtermann-Klinik
Bad Rothenfelde, Germany
Actively Recruiting
10
Universität Herzzentrum
Hamburg, Germany
Actively Recruiting
11
Osp. S.Orsola Malpighi
Bologna, Italy
Actively Recruiting
12
Fondazione Poliambulanza
Brescia, Italy
Actively Recruiting
13
Villa Maria Cecilia
Cotignola, Italy
Actively Recruiting
14
Policlinico San Donato S.P.A
Milan, Italy
Actively Recruiting
15
European Hospital
Roma, Italy
Actively Recruiting
16
A. Sanitaria O. Ordine Mauriziano
Torino, Italy
Actively Recruiting
17
UMC Maastricht
Maastricht, Netherlands
Actively Recruiting
18
Hospital Rambla
Santa Cruz de Tenerife, Spain
Actively Recruiting
19
Hospital Clinico De Valladolid
Valladolid, Spain
Actively Recruiting
Research Team
B
Bart Meuris
CONTACT
T
Tom Verbelen
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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