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

Last updated: June 28, 2024
Sponsor: Universitaire Ziekenhuizen KU Leuven
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05572710
S63824
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Clinical indication for replacement of the native or prosthetic aortic valve with abioprosthesis

  • 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 onlydata registration is performed) and is able to provide informed consent forparticipation in the clinical registry.

Exclusion

Exclusion Criteria:

  • Patient requires salvage surgery (according to EuroSCORE II definitions: "patientsrequiring cardiopulmonary resuscitation (external cardiac massage) en route to theoperating theatre or prior to induction of anaesthesia. This does not includecardiopulmonary resuscitation following induction of anaesthesia")

  • Not been able to provide informed consent

Study Design

Total Participants: 1000
Study Start date:
June 10, 2020
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • UZ Leuven

    Leuven, Vlaams-Brabant 3000
    Belgium

    Active - Recruiting

  • UCL St Luc

    Bruxelles,
    Belgium

    Active - Recruiting

  • ZOL

    Genk,
    Belgium

    Active - Recruiting

  • AZ Maria Middelares

    Gent,
    Belgium

    Active - Recruiting

  • UZ Gent

    Gent,
    Belgium

    Active - Recruiting

  • Rigshospitalet

    Kopenhagen,
    Denmark

    Active - Recruiting

  • Kuopio University Hospital

    Kuopio,
    Finland

    Active - Recruiting

  • CHU Nantes

    Nantes,
    France

    Active - Recruiting

  • Schüchtermann-Klinik

    Bad Rothenfelde,
    Germany

    Active - Recruiting

  • Universität Herzzentrum

    Hamburg,
    Germany

    Active - Recruiting

  • Osp. S.Orsola Malpighi

    Bologna,
    Italy

    Active - Recruiting

  • Fondazione Poliambulanza

    Brescia,
    Italy

    Active - Recruiting

  • Villa Maria Cecilia

    Cotignola,
    Italy

    Active - Recruiting

  • Policlinico San Donato S.P.A

    Milan,
    Italy

    Active - Recruiting

  • European Hospital

    Roma,
    Italy

    Active - Recruiting

  • A. Sanitaria O. Ordine Mauriziano

    Torino,
    Italy

    Active - Recruiting

  • UMC Maastricht

    Maastricht,
    Netherlands

    Active - Recruiting

  • Hospital Rambla

    Tenerife,
    Spain

    Active - Recruiting

  • Hospital Clinico De Valladolid

    Valladolid,
    Spain

    Active - Recruiting

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