Trials / Terminated
TerminatedNCT03632967
Early Feasibility Study of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 7 (actual)
- Sponsor
- 4Tech Cardio Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of the study is to generate feasibility safety and performance data for the 4Tech TriCinch Coil System in symptomatic patients suffering from moderate to severe functional tricuspid regurgitation with annular dilatation. The TriCinch Coil System is a percutaneous catheter-based medical device for tricuspid valve repair.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Tricinch Coil System Implantation | Patients enrolled in this study with all eligibility criteria confirmed will be implanted with the TriCinch Coil System. This device offers a percutaneous treatment (access through the vein at the groin) to treat the leaking tricuspid valve. |
Timeline
- Start date
- 2018-09-12
- Primary completion
- 2020-07-14
- Completion
- 2020-07-14
- First posted
- 2018-08-16
- Last updated
- 2020-07-31
Locations
9 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03632967. Inclusion in this directory is not an endorsement.