Avalus European Registry - an Observational Study to Evaluate Safety and Efficacy in a Real World Population

Recruiting

• Conditions: Aortic Valve Stenosis; Aortic Valve Insufficiency

• Registration Number: NCT05572710
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Study Timeline

• Study Start: 2020-06-10
• Study First Submitted: 2022-10-05
• Study First Submitted QC: 2022-10-05
• Study First Posted: 2022-10-10
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-28
• Last Update Posted: 2024-07-01
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite of all-cause mortality and disabling stroke	1 year	Composite of all-cause mortality and disabling stroke

Secondary Outcome Measures

Name	Time	Method
VARC-2	1 year	Mortality, stroke, bleeding complications, major vascular complications, new pacemaker implantation, prostethic valve function, composit endpoints

Trial Locations

Locations (19)

ZOL; 🇧🇪 Genk, Belgium

CHU Nantes; 🇫🇷 Nantes, France

Osp. S.Orsola Malpighi; 🇮🇹 Bologna, Italy

Universität Herzzentrum; 🇩🇪 Hamburg, Germany

Kuopio University Hospital; 🇫🇮 Kuopio, Finland

AZ Maria Middelares; 🇧🇪 Gent, Belgium

European Hospital; 🇮🇹 Roma, Italy

UCL St Luc; 🇧🇪 Bruxelles, Belgium

UZ Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium

UZ Gent; 🇧🇪 Gent, Belgium

Rigshospitalet; 🇩🇰 Kopenhagen, Denmark

Schüchtermann-Klinik; 🇩🇪 Bad Rothenfelde, Germany

Policlinico San Donato S.P.A; 🇮🇹 Milan, Italy

Villa Maria Cecilia; 🇮🇹 Cotignola, Italy

Fondazione Poliambulanza; 🇮🇹 Brescia, Italy

UMC Maastricht; 🇳🇱 Maastricht, Netherlands

A. Sanitaria O. Ordine Mauriziano; 🇮🇹 Torino, Italy

Hospital Rambla; 🇪🇸 Tenerife, Spain

Hospital Clinico De Valladolid; 🇪🇸 Valladolid, Spain