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RECRUITING
NCT07691307
NA

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

Sponsor: Jiangsu Trulive Medical Co., Ltd

View on ClinicalTrials.gov

Summary

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

Official title: 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

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2026-03-18

Completion Date

2028-08-30

Last Updated

2026-07-08

Healthy Volunteers

No

Interventions

DEVICE

TruGamma System

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

DRUG

Optimal medical therapy (OMT)

Optimal Medical Therapy

Locations (1)

Cardiovascular Institute & Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China