ClinicalTrialsFinder
RecruitingNot ApplicableNCT07691307

A Study to Evaluate the Safety and Performance of TruGamma System for Tricuspid Replacement

A Prospective, Multicenter, Randomized Controlled Clinical Trial Protocol Evaluating the Safety and Efficacy of the TruGamma Transcatheter Tricuspid Valve System in Patients With Severe Tricuspid Regurgitation

Sponsor

Jiangsu Trulive Medical Co., Ltd

Enrollment

180 participants

Start Date

Mar 18, 2026

Study Type

INTERVENTIONAL

Conditions

Tricuspid Valve RegurgitationTricuspid Valve InsufficiencyTricuspid Valve Disease

Summary

Pivotal trial to evaluate the safety and effectiveness of the TruGamma tricuspid valve replacement system

Eligibility

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Optimal medical therapy (OMT) and a medical device called TruGamma System for people with tricuspid valve disease, tricuspid valve insufficiency, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 65 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICETruGamma System

Transcatheter tricuspid valve replacement with the TruGamma System in conjunction with OMT

DRUGOptimal medical therapy (OMT)

Optimal Medical Therapy

Locations(1)

Cardiovascular Institute & Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07691307

Related Trials

The TRICURE EFS Study

NCT0650694210 locations

Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial

NCT0409714579 locations

Characteristics and Prognosis of Moderate or Severe Tricuspid Regurgitation

NCT035462311 location

EFS of the DUO System for Tricuspid Regurgitation

NCT0591390815 locations

Clinical Study of the inQB8 TTVR System (The MonarQ Study)

NCT066115798 locations