Health Trials

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

ConditionsTricuspid Valve RegurgitationTricuspid Valve DiseaseCardiovascular Diseases (CVD)Heart Valve DiseasesTricuspid Valve InsufficiencySevere Heart Valve DiseaseRandomized Controlled Trial (RCT)Symptomatic Tricuspid Regurgitation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVDyne, Inc.

About this trial

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

Eligibility criteria

Qualifiers

Age ≥18 years old

Subject is willing and able to comply with all study evaluations and provide consent

Subject must agree not to participate in any other clinical trial for a period of one year following index procedure

New York Heart Association (NYHA) Functional Class II, III, or IV and ambulatory

Disqualifiers

Subject unable or unwilling to comply with study required testing and follow-up visits

Subject is currently participating in another clinical trial (drug, biologic, or device) that has not yet completed its primary endpoint or is likely to interfere with this study

Pregnant, lactating subjects, and /or those who plan pregnancy in the period up to one year following index procedure.

Known hypersensitivity or contraindication to procedural or post-procedural medications (e.g., contrast solution, anticoagulation, etc.) which cannot be adequately managed medically

Trial design

Treatments tested in this trial

  • Transcatheter Tricuspid Valve Replacement (TTVR) with VDyne System
  • Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE System

Treatment groups

730 Participants
are divided into 3 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

VDyne, Inc.

Lead sponsor

Source ClinicalTrials.gov