Avalus European Registry - an Observational Study to Evaluate Safety and Efficacy in a Real World Population
Avalus
1 other identifier
observational
1,000
8 countries
19
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 the outcome and performance of surgical aortic valve replacement with the Avalus pericardial bioprosthesis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2020
Longer than P75 for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 10, 2020
CompletedFirst Submitted
Initial submission to the registry
October 5, 2022
CompletedFirst Posted
Study publicly available on registry
October 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedJuly 1, 2024
June 1, 2024
4.6 years
October 5, 2022
June 28, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Composite of all-cause mortality and disabling stroke
Composite of all-cause mortality and disabling stroke
1 year
Secondary Outcomes (1)
VARC-2
1 year
Eligibility Criteria
Real world population indicated for aortic valve replacement
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
UZ Leuven
Leuven, Vlaams-Brabant, 3000, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2022
First Posted
October 10, 2022
Study Start
June 10, 2020
Primary Completion
December 31, 2024
Study Completion
December 31, 2025
Last Updated
July 1, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share