Status:
RECRUITING
Avalus European Registry - an Observational Study to Evaluate Safety and Efficacy in a Real World Population
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Aortic Valve Stenosis
Aortic Valve Insufficiency
Eligibility:
All Genders
18+ years
Brief 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 t...
Detailed Description
The study is a prospective, observational, single-arm, multi-center registry. The patients must undergoing bioprosthetic aortic valve replacement with the Avalus valve. This prospective registry aims ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 10 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT05572710
Start Date
June 10 2020
End Date
December 31 2025
Last Update
July 1 2024
Active Locations (19)
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1
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
2
UCL St Luc
Brussels, Belgium
3
ZOL
Genk, Belgium
4
AZ Maria Middelares
Ghent, Belgium