About this trial
A retrospective, multinational, multicentre, observational study in patients presenting with native severe aortic valve stenosis and treated with Myval™ Transcatheter Heart Valve Series in real-world setting.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All patients of this study must have received Myval™ THV series for treatment of native severe aortic stenosis and completed a minimum of 30-day follow-up.
Disqualifiers
No
Trial population
All patients who have been treated with Myval™ THV series will be selected for the study.
Trial design
Case-only
Retrospective
Treatments tested in this trial
Myval Transcatheter Heart Valve Series
DeviceMyval™ THV is a newer-generation balloon-expandable THV characterized by a nickel-cobalt alloy frame composed of a single element - hexagon arranged in a hybrid honeycomb fashion.
Treatment groups
Trial outcomes
Primary outcomes
Safety and Effectiveness as defined by the Valve Academic Research Consortium-3 (VARC-3)
It is the composite of following * All-cause mortality * All stroke (disabling and non-disabling) * Life-threatening or disabling bleeding * Acute kidney injury (stage 2 or 3) * Major vascular complications * Moderate or severe prosthetic valve regurgitation * Conduction system disturbances resulting in a new permanent pacemaker implantation
Secondary outcomes
All-cause mortality
Number of mortality as per VARC - 3 Criteria
All stroke
Acute Kidney Injury (AKI) based on the Acute Kidney Injury Network (AKIN) System Stage 2, Stage 3 or Stage 4
Number of participants of AKI as per AKIN Network
Bleeding type 3 and 4
Number of participants for bleeding as per VARC-3 criteria
Sponsors and contacts
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