RecruitingNot ApplicableNCT07516444

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

Sponsor

VDyne, Inc.

Enrollment

730 participants

Start Date

Jul 28, 2026

Study Type

INTERVENTIONAL

Conditions

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

Summary

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE System and a medical device called Transcatheter Tricuspid Valve Replacement (TTVR) with VDyne System for people with cardiovascular diseases (cvd), heart valve diseases, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 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.

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Interventions

DEVICETranscatheter 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).

DEVICETranscatheter 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).

Locations(1)

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

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NCT07516444

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