RecruitingNCT05572710

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


Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

1,000 participants

Start Date

Jun 10, 2020

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a real-world registry study tracking the safety and effectiveness of the Avalus aortic valve bioprosthesis — a tissue replacement valve for the aorta — in patients undergoing aortic valve replacement surgery at participating hospitals across Europe. Unlike a controlled trial, this registry observes how the valve performs in normal clinical practice with diverse patients. You may be eligible if: - You are 18 years of age or older - You have a clinical need to replace your aortic valve (native or previously implanted prosthesis) with a bioprosthesis - You have been adequately informed about the registry and can provide informed consent You may NOT be eligible if: - You require emergency salvage surgery (involving CPR while being transported to the operating room) - You are unable to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(19)

UZ Leuven

Leuven, Vlaams-Brabant, Belgium

UCL St Luc

Brussels, Belgium

ZOL

Genk, Belgium

AZ Maria Middelares

Ghent, Belgium

UZ Gent

Ghent, Belgium

Rigshospitalet

Copenhagen, Denmark

Kuopio University Hospital

Kuopio, Finland

CHU Nantes

Nantes, France

Schüchtermann-Klinik

Bad Rothenfelde, Germany

Universität Herzzentrum

Hamburg, Germany

Osp. S.Orsola Malpighi

Bologna, Italy

Fondazione Poliambulanza

Brescia, Italy

Villa Maria Cecilia

Cotignola, Italy

Policlinico San Donato S.P.A

Milan, Italy

European Hospital

Roma, Italy

A. Sanitaria O. Ordine Mauriziano

Torino, Italy

UMC Maastricht

Maastricht, Netherlands

Hospital Rambla

Santa Cruz de Tenerife, Spain

Hospital Clinico De Valladolid

Valladolid, Spain

View Full Details on ClinicalTrials.gov

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NCT05572710


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