Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06162780
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2023-11-30
Brief Title:
TEER for Severe DMR of Low to Intermediate Surgery Risk
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:
The Efficacy and Safety of TEER for Severe DMR Patients of Low to Intermediate Surgery Risk TESLA-R--a Multi-center Prospective Cohort Study
Status:
RECRUITING
Status Verified Date:
2024-03
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:
To investigate the efficacy and safety of transcatheter mitral valve edge-to-edge repair TEER for severe degenerative mitral regurgitation DMR patients of low to intermediate surgery risk
Detailed Description:
This is a proposed multicentre prospective cohort study to enrol and follow up severe DMR patients of low to intermediate surgery risk who underwent TEER and surgical historical controls The primary efficacy endpoints are all-cause death and cumulative composite event rate of worsening heart failure at 24 months postoperatively and the primary safety endpoints are death secondary surgery and various complications at 30 days postoperatively The study aims to investigate the efficacy and safety of TEER in surgical low-intermediate-risk patients with severe DMR and to inform the subsequent clinical application
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None