Ignite Creation Date:
2024-05-06 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05737264
Status:
RECRUITING
Last Update Posted:
2023-05-30
First Post:
2023-01-29
Brief Title:
TAVR in Adults With Pure Severe Aortic Regurgitation
Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Organization:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Overview
Official Title:
Safety and Effectiveness of Transcatheter Treatment of Severe Native Aortic Regurgitation With Self-Expandable Valve Implantation a Multicenter ObservationalCohort StudySENSE-AR
Status:
RECRUITING
Status Verified Date:
2023-01
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:
SENSE-AR
Brief Summary:
The study aimed to evaluate the efficacy and safety of transcatheter aortic valve replacement TAVR in patients with severe native valve aortic insufficiency It is a multicentre observational cohort study The primary endpoint consisted of a composite of all-cause death disabling stroke or rehospitalization for heart failure at 12 months postoperatively According to previous research results and opinions of expert groups the sample size was expected to be 76 cases
Detailed Description:
None
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