About this trial
The issue of valve durability has become one of the most important aspects in the TAVR field in recent years since transcatheter aortic valve replacement has been progressively applied to younger patients with a low co-morbidity burden. The SAPIEN 3 Ultra RESILIA valve represents the last generation of the SAPIEN valve system and includes several important iterations (newer leaflet calcium-blocking technology targeting calcium-attracting free aldehydes, dry tissue storage, newer skirt textile design) that should translate into a favorable impact on valve durability at mid- to long- term follow-up
Eligibility criteria
Qualifiers
Inclusion criteria - Patients with severe aortic stenosis undergoing transarterial TAVR with the SAPIEN 3 Ultra RESILIA valve.
Successful valve implantation of the SAPIEN 3 Ultra RESILIA valve.
Freedom from mortality
Successful access, delivery of the device, and retrieval of the delivery system
Disqualifiers
Age >80 years
Severe pulmonary disease (FEV1 <50% predicted or need for home oxygen)
Severe renal dysfunction (eGFR <30 ml/min/1.73m2)
Frailty (Clinical Frailty Scale > 4)
Trial design
Treatments tested in this trial
- SAPIEN 3 Ultra RESILIA Valve
Treatment groups
Locations
1Sponsors and collaborators
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Lead sponsor