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

NCT ID: NCT05572710

Last Updated: 2024-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-10

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Aortic Valve Stenosis Aortic Valve Insufficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UZ Leuven

Leuven, Vlaams-Brabant, Belgium

Site Status RECRUITING

UCL St Luc

Brussels, , Belgium

Site Status RECRUITING

ZOL

Genk, , Belgium

Site Status RECRUITING

AZ Maria Middelares

Ghent, , Belgium

Site Status RECRUITING

UZ Gent

Ghent, , Belgium

Site Status RECRUITING

Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

Kuopio University Hospital

Kuopio, , Finland

Site Status RECRUITING

CHU Nantes

Nantes, , France

Site Status RECRUITING

Schüchtermann-Klinik

Bad Rothenfelde, , Germany

Site Status RECRUITING

Universität Herzzentrum

Hamburg, , Germany

Site Status RECRUITING

Osp. S.Orsola Malpighi

Bologna, , Italy

Site Status RECRUITING

Fondazione Poliambulanza

Brescia, , Italy

Site Status RECRUITING

Villa Maria Cecilia

Cotignola, , Italy

Site Status RECRUITING

Policlinico San Donato S.P.A

Milan, , Italy

Site Status RECRUITING

European Hospital

Roma, , Italy

Site Status RECRUITING

A. Sanitaria O. Ordine Mauriziano

Torino, , Italy

Site Status RECRUITING

UMC Maastricht

Maastricht, , Netherlands

Site Status RECRUITING

Hospital Rambla

Santa Cruz de Tenerife, , Spain

Site Status RECRUITING

Hospital Clinico De Valladolid

Valladolid, , Spain

Site Status RECRUITING

Countries

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Belgium Denmark Finland France Germany Italy Netherlands Spain

Central Contacts

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Bart Meuris

Role: CONTACT

[email protected]
+32 16 344260

Tom Verbelen

Role: CONTACT

[email protected]
+32 16 344260

Facility Contacts

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Bart Meuris

Role: primary

[email protected]
+3216344260

Tom Verbelen

Role: backup

[email protected]
+3116344260

Laurent de Kerckhove

Role: primary

Chris Van Kerrebroeck

Role: primary

Koen Cathenis

Role: primary

Katrien Francois

Role: primary

Jesper Ravn

Role: primary

Pekka Jaakkola

Role: primary

J. Roussel

Role: primary

Nicolas Doll

Role: primary

Hermann Reichenspurner

Role: primary

D. Pacini

Role: primary

G. Troise

Role: primary

Alberto Giovanni Tripodi

Role: primary

A. Canziani

Role: primary

R. De Paulis

Role: primary

P. Centofanti

Role: primary

Roberto Lorusso

Role: primary

Rafael Llorens

Role: primary

Juan Bustamante

Role: primary

Other Identifiers

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S63824

Identifier Type: -

Identifier Source: org_study_id

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