NCT05434507

Feasibility Study of Treating Tricuspid Regurgitation With K-ClipTM Transcatheter Annuloplasty System

Feasibility Study of Treating Tricuspid Regurgitation With K-ClipTM Transcatheter

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Shanghai Huihe Medical Technology Co., Ltd · Industry
• Sex: All
• Age: 60 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the effectiveness and safety of the transcatheter tricuspid annuloplasty system manufactured by Shanghai Huihe Medical Technology Co., Ltd. for the treatment of patients with moderate-severe or worse tricuspid regurgitation

Conditions

• Tricuspid Regurgitation

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: 2021-09-16
• Primary completion: 2026-09-16
• Completion: 2026-09-16
• First posted: 2022-06-28
• Last updated: 2022-06-28

Locations

1 site across 1 country: China