NCT07433504

A Prospective, Multicenter, Randomized Controlled Clinical Trial of Transcatheter Tricuspid Valve Clipping Systems.

A Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Transcatheter Tricuspid Valve Clipping Systems in Patients With Severe or Greater Tricuspid Regurgitation.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: Shanghai Huihe Medical Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The transcatheter tricuspid valve clipping system is specially designed for the treatment of tricuspid regurgitation. Under the guidance of ultrasound and DSA imaging, the investigational device is advanced into the right ventricle via a femoral or jugular venous puncture approach. The clipping component grasps the edges of the dysfunctional valve leaflets (usually unable to close properly), thereby reducing the area of the tricuspid orifice that fails to coapt normally, achieving minimally invasive treatment of tricuspid regurgitation.

Conditions

• Severe or Greater Tricuspid Regurgitation

Interventions

Type	Name	Description
DEVICE	Experimental: Transcatheter tricuspid valve repair using the transcatheter tricuspid valve clipping system +GDMT	This is a prospective, multi-center, randomized controlled clinical trial. Eligible patients with severe or greater tricuspid regurgitation will be enrolled in accordance with the inclusion and exclusion criteria specified in the study protocol. A total of 132 patients who meet all inclusion criteria and none of the exclusion criteria during pre-treatment screening will be randomized in a 2:1 ratio to either the experimental group or the control group.
DRUG	Guideline Directed Medical Therapy	Guideline Directed Medical Therapy

Timeline

• Start date: 2026-01-28
• Primary completion: 2027-12-31
• Completion: 2031-12-31
• First posted: 2026-02-25
• Last updated: 2026-02-25

Locations

1 site across 1 country: China