Ignite Creation Date:
2024-05-06 @ 12:23 PM
Last Modification Date:
2024-10-26 @ 12:58 PM
Study NCT ID:
NCT03745313
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-04-03
First Post:
2018-11-13
Brief Title:
Edwards CLASP TR EFS
Sponsor:
Edwards Lifesciences
Organization:
Edwards Lifesciences
Study Overview
Official Title:
Edwards PASCAL TrAnScatheter Valve RePair System in Tricuspid Regurgitation CLASP TR Early Feasibility Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
CLASP TR EFS
Brief Summary:
Early feasibility study to assess the safety and performance of the Edwards PASCAL Transcatheter Valve Repair System in tricuspid regurgitation
Detailed Description:
The study is a multi-center prospective single-arm and non-randomized study designed to evaluate the safety and performance of the Edwards PASCAL Transcatheter Valve Repair System
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None