Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06420830
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-05-15
Brief Title:
Valve Performance of the SAPIEN 3 Ultra RESILIA Valve A Prospective Registry With Central Echocardiography Analysis
Sponsor:
Institut universitaire de cardiologie et de pneumologie de Québec University Laval
Organization:
Institut universitaire de cardiologie et de pneumologie de Québec University Laval
Study Overview
Official Title:
Title Valve Performance of the SAPIEN 3 Ultra RESILIA Valve A Prospective Registry With Central Echocardiography Analysis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Prospective observational registry including patients with severe aortic stenosis undergoing TAVR with the SAPIEN 3 Ultra RESILIA valve All patients who will survive the procedure will undergo a clinical and echocardiographic follow-up at 1-3 months 15 days at 1-year 30 days 3-5 year 30 days 6-8 year 30 days and 9-10 year 30 days after valve implantation Transthoracic echocardiography TTE exams baseline 1-3-month 1 year 3-5 years 6-8 years and 9-10 years post-procedure will be evaluated in a Centralized Echocardiographic Core Lab at the Quebec Heart and Lung Institute The measurements obtained in the Core Lab regarding transvalvular gradient EOA PPM and PVL at 1-3 months will determine the primary outcome of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None