Clinical trial NCT05572710: Avalus European Registry - an Observational Study to Evaluate Safety and Efficacy in a Real World Population
Official title: Avalus European Registry - an Observational Study to Evaluate Safety and Efficacy in a Real World Population
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Valve Stenosis
Aortic Valve Insufficiency
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2022-10-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Real world population indicated for aortic valve replacement

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.

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 to examine the outcome and performance of surgical aortic valve replacement with the Avalus pericardial bioprosthesis.

The goal of this project is to evaluate the real world results of aortic valve replacement with the Avalus valve. This will result in clinical and hemodynamic knowledge of this particular valve. The investigators are aiming for 1000 patient inclusions distributed over 40 sites across Europe and potentially also involving Canada.

Intentionally, we kept the inclusion criteria as wide as possible in order to obtain a real-world experience with and performance of the bioprosthesis. Patients younger than 18 years and salvage procedures are the only exclusion criteria from the registry. Outcome is evaluated in accordance with the VARC-2 criteria up to 1-year postoperatively.

Eligibility criteria: 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

Primary outcomes:
measure: Composite of all-cause mortality and disabling stroke
timeFrame: 1 year
Secondary outcomes:
measure: VARC-2
timeFrame: 1 year
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
city: Bruxelles
country: Belgium
facility: UCL St Luc
city: Genk
country: Belgium
facility: ZOL
city: Gent
country: Belgium
facility: AZ Maria Middelares
city: Gent
country: Belgium
facility: UZ Gent
city: Kopenhagen
country: Denmark
facility: Rigshospitalet
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Nantes
country: France
facility: CHU Nantes
city: Bad Rothenfelde
country: Germany
facility: Schüchtermann-Klinik
city: Hamburg
country: Germany
facility: Universität Herzzentrum
city: Bologna
country: Italy
facility: Osp. S.Orsola Malpighi
city: Brescia
country: Italy
facility: Fondazione Poliambulanza
city: Cotignola
country: Italy
facility: Villa Maria Cecilia
city: Milan
country: Italy
facility: Policlinico San Donato S.P.A
city: Roma
country: Italy
facility: European Hospital
city: Torino
country: Italy
facility: A. Sanitaria O. Ordine Mauriziano
city: Maastricht
country: Netherlands
facility: UMC Maastricht
city: Tenerife
country: Spain
facility: Hospital Rambla
city: Valladolid
country: Spain
facility: Hospital Clinico De Valladolid
Study officials:
References: