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

Sponsor
Universitaire Ziekenhuizen KU Leuven (Other)
Overall Status
Recruiting
CT.gov ID
NCT05572710
Collaborator
(none)
1,000
Enrollment
19
Locations
66.7
Anticipated Duration (Months)
52.6
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    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. We 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 Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Avalus European Registry - an Observational Study to Evaluate Safety and Efficacy in a Real World Population
    Actual Study Start Date :
    Jun 10, 2020
    Anticipated Primary Completion Date :
    Dec 31, 2024
    Anticipated Study Completion Date :
    Dec 31, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Composite of all-cause mortality and disabling stroke [1 year]

      Composite of all-cause mortality and disabling stroke

    Secondary Outcome Measures

    1. VARC-2 [1 year]

      Mortality, stroke, bleeding complications, major vascular complications, new pacemaker implantation, prostethic valve function, composit endpoints

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UZ Leuven Leuven Vlaams-Brabant Belgium 3000
    2 UCL St Luc Bruxelles Belgium
    3 ZOL Genk Belgium
    4 AZ Maria Middelares Gent Belgium
    5 UZ Gent Gent Belgium
    6 Rigshospitalet Kopenhagen Denmark
    7 Kuopio University Hospital Kuopio Finland
    8 CHU Nantes Nantes France
    9 Schüchtermann-Klinik Bad Rothenfelde Germany
    10 Universität Herzzentrum Hamburg Germany
    11 Osp. S.Orsola Malpighi Bologna Italy
    12 Fondazione Poliambulanza Brescia Italy
    13 Villa Maria Cecilia Cotignola Italy
    14 Policlinico San Donato S.P.A Milan Italy
    15 European Hospital Roma Italy
    16 A. Sanitaria O. Ordine Mauriziano Torino Italy
    17 UMC Maastricht Maastricht Netherlands
    18 Hospital Rambla Tenerife Spain
    19 Hospital Clinico De Valladolid Valladolid Spain

    Sponsors and Collaborators

    • Universitaire Ziekenhuizen KU Leuven

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Universitaire Ziekenhuizen KU Leuven
    ClinicalTrials.gov Identifier:
    NCT05572710
    Other Study ID Numbers:
    • S63824
    First Posted:
    Oct 10, 2022
    Last Update Posted:
    Oct 10, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Aortic Valve Stenosis
    Aortic Valve Insufficiency

    Study Results

    No Results Posted as of Oct 10, 2022