Ignite Creation Date:
2024-05-06 @ 7:09 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05913908
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2023-05-31
Brief Title:
EFS of the DUO System for Tricuspid Regurgitation TANDEM II
Sponsor:
CroiValve Limited
Organization:
CroiValve Limited
Study Overview
Official Title:
Early Feasibility Study of the DUO Transcatheter Tricuspid Coaptation Valve System in Patients With Tricuspid Regurgitation
Status:
RECRUITING
Status Verified Date:
2024-06
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:
TANDEM II
Brief Summary:
The study is an early feasibility study to measure individual patient clinical outcomes and effectiveness evaluate the safety and function of the DUO Transcatheter Tricuspid Coaptation Valve System DUO System
Detailed Description:
Multi-center prospective non-randomized investigational and pre-market Data collected in this clinical study will include safety and function of the investigational system as well as up to 5 year clinical outcomes
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?:
None
Is an FDA AA801 Violation?:
None