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

NCT07691307 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-07-08

No results posted yet for this study

Summary

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

Conditions

  • Tricuspid Valve Regurgitation
  • Tricuspid Valve Insufficiency
  • Tricuspid Valve Disease

Interventions

DEVICE

TruGamma System

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

DRUG

Optimal medical therapy (OMT)

Optimal Medical Therapy

Sponsors & Collaborators

  • Jiangsu Trulive Medical Co., Ltd

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-18
Primary Completion
2028-08-30
Completion
2028-08-30

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 NCT07691307 on ClinicalTrials.gov