Trials / Not Yet Recruiting

Not Yet RecruitingNCT07516444

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

VDyne Transcatheter Tricuspid Valve Replacement Study to Evaluate Safety and Clinical Efficacy in Patients With Symptomatic Severe Tricuspid Valve Regurgitation

Status: Not Yet Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 730 (estimated)

Sponsor: VDyne, Inc. · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

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

Detailed description

The clinical trial is a prospective, multi-center, randomized controlled pivotal trial to evaluate the safety and effectiveness of the VDyne Transcatheter Tricuspid Valve Replacement (TTVR) System compared to Edwards EVOQUE TTVR System in symptomatic patients with severe or greater tricuspid regurgitation. Subjects will be followed at discharge, 30 days, 3 months, 6 months and annually through 5 years.

Conditions

Interventions

Type	Name	Description
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).

Timeline

Start date: 2026-06-01
Primary completion: 2029-06-01
Completion: 2036-06-01
First posted: 2026-04-08
Last updated: 2026-04-08

Regulatory

FDA-regulated device study

Source: ClinicalTrials.gov record NCT07516444. Inclusion in this directory is not an endorsement.