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VDyne Transcatheter Tricuspid Valve Replacement Study to Evaluate Safety and Clinical Efficacy in Patients With Symptomatic Severe Tricuspid Valve Regurgitation (TRIVITA Pivotal Trial)

NCT07516444 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 730

Last updated 2026-04-08

No results posted yet for this study

Summary

Pivotal trial to evaluate the safety and clinical efficacy of the VDyne System for the treatment of symptomatic severe or greater tricuspid regurgitation.

Conditions

  • Tricuspid Valve Regurgitation
  • Tricuspid Valve Disease
  • Cardiovascular Diseases (CVD)
  • Heart Valve Diseases
  • Tricuspid Valve Insufficiency
  • Severe Heart Valve Disease
  • Randomized Controlled Trial (RCT)
  • Symptomatic Tricuspid Regurgitation

Interventions

DEVICE

Transcatheter Tricuspid Valve Replacement (TTVR) with VDyne System

Subjects will undergo TTVR procedure with VDyne device and will continue to be managed on Optimal Medical Therapy (OMT).

DEVICE

Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE System

Subjects will undergo TTVR procedure with Edwards EVOQUE device and will continue to be managed on Optimal Medical Therapy (OMT).

Sponsors & Collaborators

  • VDyne, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2029-06-30
Completion
2036-06-30
FDA Device
Yes

More Related Trials

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 NCT07516444 on ClinicalTrials.gov