Avalus European Registry - an Observational Study to Evaluate Safety and Efficacy in a Real World Population
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
Real world population indicated for aortic valve replacement
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Composite of all-cause mortality and disabling stroke
Composite of all-cause mortality and disabling stroke
Time frame
1 yearSecondary outcomes
1
VARC-2
Mortality, stroke, bleeding complications, major vascular complications, new pacemaker implantation, prostethic valve function, composit endpoints
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov