Trials / Not Yet Recruiting
Not Yet RecruitingNCT05173233
Confirmatory Clinical Study of Treating Tricuspid Regurgitation With K-Clip TM Transcatheter Annuloplasty System
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 67 (estimated)
- Sponsor
- Shanghai Huihe Medical Technology Co., Ltd · Industry
- Sex
- All
- Age
- 60 Years
- Healthy volunteers
- Not accepted
Summary
The present clinical trial is performed to evaluate the effectiveness and safety of transcatheter tricuspid annuloplasty system manufactured by Shanghai Huihe Healthcare technology Co.,Ltd. for the treatment of subjects with severe or worse tricuspid regurgitation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Transcatheter Annuloplasty | Under echocardiography guidance, the transcatheter tricuspid annuloplasty system precisely reaches the specified position in the tricuspid valve region via jugular vein and superior vena cava approach. The enlarged tricuspid annular tissue is clamped with the clamp cpart and anchor part to reduce the perimeter of tricuspid annulus, so that the area of tricuspid orifice that could not be coapted is reduced. It plays the purpose of minimally invasive treatment of tricuspid valve. |
Timeline
- Start date
- 2022-05-15
- Primary completion
- 2023-05-15
- Completion
- 2027-05-15
- First posted
- 2021-12-29
- Last updated
- 2022-04-21
Source: ClinicalTrials.gov record NCT05173233. Inclusion in this directory is not an endorsement.