Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TriCinch System · 1 trial · 1 indication
Freedom from major adverse event: death, Q-wave myocardial infarction, cardiac tamponade, cardiac surgery for failed TriCinch implantation, stroke, or septicaemia.
Ability to reduce tricuspid regurgitation by at least 1 degree immediately following implantation of the TriCinch device assessed by means of quantitative echocardiographic parameters.
Ability to reduce tricuspid regurgitation by at least 1 degree immediately following implantation of the TriCinch device assessed by means of quantitative echocardiographic parameters.
| Arm | Type | Description |
|---|---|---|
| Percutaneous treatment of TR by TriCinch | EXPERIMENTAL | Percutaneous treatment of Tricuspid Regurgitation with TriCinch System |
| Name | Type | Description |
|---|---|---|
| TriCinch System | DEVICE | Percutaneous treatment of Tricuspid Regurgitation |
Inclusion Criteria: * Functional symptomatic tricuspid regurgitation (TR) 2+ to 4+ on a scale of 4+ (moderate to severe), with annular dilatation greater than 40mm. * Signed informed consent form prior to any study-related procedure. * Available and able to return to the study site for post-procedu...
The TriCinch System is an investigational device being studied for the treatment of tricuspid regurgitation, a condition where the tricuspid valve does not close properly, causing blood to flow backward into the right atrium. It is currently in Phase 1 clinical development.
The TriCinch System is being developed by Cardio Diagnostics Holdings Inc., a company traded on the stock exchange under the ticker symbol CDIO. The device is intended for percutaneous treatment of tricuspid valve regurgitation.
The TriCinch System is in Phase 1 clinical development. One Phase 1 trial has been completed, and the device remains investigational, meaning it has not yet been approved for commercial use.
The TriCinch System has been studied in one completed Phase 1 clinical trial, identified as NCT02098200. This trial, titled 'Percutaneous Treatment of Tricuspid Valve Regurgitation With the TriCinch System™,' enrolled 24 participants with tricuspid regurgitation across France, Germany, Italy, and the Netherlands.
The TriCinch System is not FDA approved. It is an investigational device currently in Phase 1 clinical development. A completed Phase 1 trial has evaluated its use in patients with tricuspid regurgitation, but it has not yet received regulatory approval.