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

NCT07433504 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2026-02-25

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Shanghai Huihe Medical Technology Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-28
Primary Completion
2027-12-31
Completion
2031-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07433504 on ClinicalTrials.gov