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

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
VDyne, Inc.
Study ID
NCT07516444
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Transcatheter Tricuspid Valve Replacement (TTVR) with VDyne System — DEVICE
    Subjects will undergo TTVR procedure with VDyne device and will continue to be managed on Optimal Medical Therapy (OMT).
  • Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE System — DEVICE
    Subjects will undergo TTVR procedure with Edwards EVOQUE device and will continue to be managed on Optimal Medical Therapy (OMT).

Study Details

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

Key Dates

First listed
Apr 8, 2026
Start date
Jul 28, 2026
Status verified
Aug 2026
Primary completion
Jun 30, 2029
Completion
Jun 30, 2036

Study Design

Enrollment
730 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Randomized cohort VDyne TTVR
    Transcatheter tricuspid valve replacement with VDyne System in patients with severe or greater tricuspid regurgitation.
  • Active Comparator: Randomized cohort Edwards EVOQUE TTVR
    Transcatheter tricuspid valve replacement with Edwards EVOQUE System in patients with severe or greater tricuspid regurgitation.
  • Experimental: Single Arm Registry
    Transcatheter tricuspid valve replacement with VDyne System in patients with severe or greater tricuspid regurgitation who are deemed ineligible to be treated with Active Comparator EVOQUE device.

Primary Outcome Measure

Composite of major adverse events (MAEs) [ Time Frame: 30 days post-procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Minneapolis Heart Institute FoundationMinneapolisMinnesota55407
Nikki Clinical Research Manager
[email protected]
6128636286
Konstantinos Voudris (PRINCIPAL_INVESTIGATOR)

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By research site
Minneapolis Heart Institute Foundation· Minneapolis, MN

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