Registry to evaluate the safety and effectiveness of the Avalus aortic valve

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

This study is testing how safe and effective the Avalus aortic valve is for patients getting a heart valve replacement.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Universitaire Ziekenhuizen KU Leuven (Academic / other)
• Locations: 19 sites (Leuven, Vlaams-Brabant and 18 other locations)
• Trial ID: NCT05572710 on ClinicalTrials.gov

What this trial studies

This is a prospective, observational, single-arm, multi-center registry that focuses on patients undergoing bioprosthetic aortic valve replacement with the Avalus valve. The study aims to gather real-world data on the outcomes and performance of this specific bioprosthesis. With a target of including 1000 patients across 40 sites in Europe and potentially Canada, the registry will evaluate results based on VARC-2 criteria up to one year post-surgery. The inclusion criteria are broad to capture a wide range of patient experiences, while only excluding those under 18 and those requiring salvage procedures.

Who should consider this trial

Good fit: Ideal candidates for this registry are adults aged 18 and older who require a bioprosthetic aortic valve replacement.

Not a fit: Patients who are under 18 years old or those requiring salvage surgery will not benefit from this study.

Why it matters

Potential benefit: If successful, this registry could provide valuable insights into the safety and effectiveness of the Avalus valve, potentially improving patient outcomes in aortic valve replacement.

How similar studies have performed: Other studies have shown success with similar observational approaches in evaluating surgical outcomes, making this a promising endeavor.

Eligibility criteria

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

Where this trial is running

Leuven, Vlaams-Brabant and 18 other locations

• UZ Leuven — Leuven, Vlaams-Brabant, Belgium (Recruiting)
• UCL St Luc — Brussels, Belgium (Recruiting)
• Zol — Genk, Belgium (Recruiting)
• AZ Maria Middelares — Ghent, Belgium (Recruiting)
• UZ Gent — Ghent, Belgium (Recruiting)
• Rigshospitalet — Copenhagen, Denmark (Recruiting)
• Kuopio University Hospital — Kuopio, Finland (Recruiting)
• CHU Nantes — Nantes, France (Recruiting)
• Schüchtermann-Klinik — Bad Rothenfelde, Germany (Recruiting)
• Universität Herzzentrum — Hamburg, Germany (Recruiting)
• Osp. S.Orsola Malpighi — Bologna, Italy (Recruiting)
• Fondazione Poliambulanza — Brescia, Italy (Recruiting)
• Villa Maria Cecilia — Cotignola, Italy (Recruiting)
• Policlinico San Donato S.P.A — Milan, Italy (Recruiting)
• European Hospital — Roma, Italy (Recruiting)
• A. Sanitaria O. Ordine Mauriziano — Torino, Italy (Recruiting)
• UMC Maastricht — Maastricht, Netherlands (Recruiting)
• Hospital Rambla — Santa Cruz de Tenerife, Spain (Recruiting)
• Hospital Clinico De Valladolid — Valladolid, Spain (Recruiting)

Study contacts

• Study coordinator: Bart Meuris

Conditions Aortic Valve Stenosis; Aortic Valve Insufficiency