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

June 28, 2024 updated by: Universitaire Ziekenhuizen KU Leuven
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.

Study Overview

Status

Recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Bruxelles, Belgium
        • Recruiting
        • UCL St Luc
        • Contact:
          • Laurent de Kerckhove
      • Genk, Belgium
        • Recruiting
        • ZOL
        • Contact:
          • Chris Van Kerrebroeck
      • Gent, Belgium
        • Recruiting
        • UZ Gent
        • Contact:
          • Katrien Francois
      • Gent, Belgium
        • Recruiting
        • AZ Maria Middelares
        • Contact:
          • Koen Cathenis
    • Vlaams-Brabant
  • Denmark
      • Kopenhagen, Denmark
        • Recruiting
        • Rigshospitalet
        • Contact:
          • Jesper Ravn
  • Finland
      • Kuopio, Finland
        • Recruiting
        • Kuopio University Hospital
        • Contact:
          • Pekka Jaakkola
  • France
      • Nantes, France
        • Recruiting
        • CHU Nantes
        • Contact:
          • J. Roussel
  • Germany
      • Bad Rothenfelde, Germany
        • Recruiting
        • Schüchtermann-Klinik
        • Contact:
          • Nicolas Doll
      • Hamburg, Germany
        • Recruiting
        • Universität Herzzentrum
        • Contact:
          • Hermann Reichenspurner
  • Italy
      • Bologna, Italy
        • Recruiting
        • Osp. S.Orsola Malpighi
        • Contact:
          • D. Pacini
      • Brescia, Italy
        • Recruiting
        • Fondazione Poliambulanza
        • Contact:
          • G. Troise
      • Cotignola, Italy
        • Recruiting
        • Villa Maria Cecilia
        • Contact:
          • Alberto Giovanni Tripodi
      • Milan, Italy
        • Recruiting
        • Policlinico San Donato S.P.A
        • Contact:
          • A. Canziani
      • Roma, Italy
        • Recruiting
        • European Hospital
        • Contact:
          • R. De Paulis
      • Torino, Italy
        • Recruiting
        • A. Sanitaria O. Ordine Mauriziano
        • Contact:
          • P. Centofanti
  • Netherlands
      • Maastricht, Netherlands
        • Recruiting
        • UMC Maastricht
        • Contact:
          • Roberto Lorusso
  • Spain
      • Tenerife, Spain
        • Recruiting
        • Hospital Rambla
        • Contact:
          • Rafael Llorens
      • Valladolid, Spain
        • Recruiting
        • Hospital Clínico de Valladolid
        • Contact:
          • Juan Bustamante

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Real world population indicated for aortic valve replacement

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of all-cause mortality and disabling stroke
Time Frame: 1 year
Composite of all-cause mortality and disabling stroke
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VARC-2
Time Frame: 1 year
Mortality, stroke, bleeding complications, major vascular complications, new pacemaker implantation, prostethic valve function, composit endpoints
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2020

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

October 5, 2022

First Submitted That Met QC Criteria

October 5, 2022

First Posted (Actual)

October 10, 2022

Study Record Updates

Last Update Posted (Actual)

July 1, 2024

Last Update Submitted That Met QC Criteria

June 28, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S63824

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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