Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2026-03-01 @ 12:07 PM
Study NCT ID:
NCT03700918
Status:
UNKNOWN
Last Update Posted:
2021-11-12
First Post:
2017-12-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
First in Human Study of the DaVingi™ TR System in the Treatment of Patients With Functional Tricuspid Regurgitation
Sponsor:
Cardiac Implants LLC
Organization:
Study Overview
Official Title:
A First in Human Study to Assess Safety and Performance of the DaVingi™ System in the Treatment of Patients With Functional Tricuspid Regurgitation
Status:
UNKNOWN
Status Verified Date:
2021-11
Last Known Status:
RECRUITING
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 DaVingi™ System is a percutaneous trans-catheter device delivered using right heart catheterization through the right internal jugular vein. The DaVingi™ System is designed for performing ring annuloplasty by using a Ring Delivery System to place a complete, flexible fabric ring around the annulus of the atrial side of the tricuspid valve. Fluoroscopy and echocardiography are used to monitor the ring placement procedure.
Detailed Description:
The annuloplasty ring is a small multi-element ring, consisting of an outer fabric layer, a pre-set stakes array and internal adjustment cord that can be adjusted at a later stage after the outer layer of the ring and stakes are encapsulated in new tissue growth. Once implanted, the ring is designed to serve as a foundation for promoting new annular tissue growth, effectively growing a new adjustable annulus around the valve.
the study has been approved by Institutional Review Boards and Competent Authorities in Czech Republic, France and Israel.
the study has been approved by Institutional Review Boards and Competent Authorities in Czech Republic, France and Israel.
Study Oversight
Has Oversight DMC:
False
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?: