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

Aortic Valve Stenosis Clinical Trial

— Avalus  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05572710
• Other study ID #: S63824
• Status: Recruiting
• Start date: June 10, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: July 2022
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Bart Meuris
• Phone: +32 16 344260
• Email: bart.meuris[@]uzleuven.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Insufficiency
• Aortic Valve Stenosis

Locations

Country	Name	City	State
Belgium	UCL St Luc	Bruxelles
Belgium	ZOL	Genk
Belgium	AZ Maria Middelares	Gent
Belgium	UZ Gent	Gent
Belgium	UZ Leuven	Leuven	Vlaams-Brabant
Denmark	Rigshospitalet	Kopenhagen
Finland	Kuopio University Hospital	Kuopio
France	CHU Nantes	Nantes
Germany	Schüchtermann-Klinik	Bad Rothenfelde
Germany	Universität Herzzentrum	Hamburg
Italy	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
Netherlands	UMC Maastricht	Maastricht
Spain	Hospital Rambla	Tenerife
Spain	Hospital Clinico De Valladolid	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Countries where clinical trial is conducted

Belgium,  Denmark,  Finland,  France,  Germany,  Italy,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of all-cause mortality and disabling stroke	Composite of all-cause mortality and disabling stroke	1 year
Secondary	VARC-2	Mortality, stroke, bleeding complications, major vascular complications, new pacemaker implantation, prostethic valve function, composit endpoints	1 year