Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: A Prospective Registry With Central Echocardiography Analysis.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorInstitut universitaire de cardiologie et de pneumologie de Québec, University Laval

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

No treatment groups listed