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NCT06420830

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

Title Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: A Prospective Registry With Central Echocardiography Analysis.
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval·ClinicalTrials.gov·procedureNot yet recruiting
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Study focus
Disease/Condition
Aortic Valve Stenosis,Transcatheter Aortic Valve Replacement
Drug/Device/Intervention
SAPIEN 3 Ultra RESILIA Valve
Study type
Observational
Intervention type
procedure
Sponsor & location
Primary sponsor
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Location
Quebec, Canada
Timeline & enrollment
Phase
N/A
Start date
Jun 01, 2024
End date
Sep 01, 2034
Enrollment
150 participants
Primary outcome

Transvalvular gradient,Effective orifice area (EOA),Prosthesis-patient mismatch,Paravalvular leaks

Summary

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

ICD-10 classifications
Aortic (valve) stenosisCongenital stenosis of aortic valveAortic (valve) stenosis with insufficiencyStenosis of aortaAortic valve disorder, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06420830
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06420830 through Pure Global AI's free database. This phase not specified trial is sponsored by Institut universitaire de cardiologie et de pneumologie de Québec, University Laval and is currently Not yet recruiting. The study focuses on Aortic Valve Stenosis,Transcatheter Aortic Valve Replacement. Target enrollment is 150 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.