Recruiting

VDyne System

Sponsor:

VDyne, Inc.

Code:

NCT07516444

Conditions

Tricuspid Valve Regurgitation

Tricuspid Valve Disease

Cardiovascular Diseases (CVD)

Heart Valve Diseases

Tricuspid Valve Insufficiency

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Transcatheter Tricuspid Valve Replacement (TTVR) with VDyne System

Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE System

Study Details

Brief 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

Study ID

NCT07516444

Start date

Jul 28, 2026

Status verified date

Aug, 2026

Completion date

Jun, 2036

Anticipated

Primary completion date

Jun, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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
  • At least severe symptomatic tricuspid regurgitation.
  • Despite adequate and Optimized Medical Therapy (OMT), subject has signs and symptoms from TR, or prior heart failure hospitalization from TR
  • Heart team determines that the subject is appropriate for transcatheter tricuspid valve replacement
  • Functional and/or degenerative TR graded as at least severe

Exclusion Criteria:

  • 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
  • Life expectancy ≤12 months due to non-cardiac comorbidities
  • Current IV Drug user (must be free from drug abuse for ≥1 year)
  • Subject unable or unwilling to provide written, informed consent before study enrollment
  • Tricuspid valve anatomy (cardiac and vascular) that is not suitable for the VDyne System
  • Hypersensitivity to metals (such as nickel or titanium)
  • Prior tricuspid valve surgery or catheter-based therapy with permanent residual device(s) implanted that would preclude delivery or implantation of the VDyne valve (e.g., valve replacement, edge to edge repair, etc.)
  • Severe valvular heart disease using established echocardiographic criteria requiring intervention other than the tricuspid valve
  • Known significant intracardiac shunt (e.g., septal defect).
  • Cerebrovascular accident (stroke, TIA) within 90 days of treatment procedure
  • Severe lung disease (severe COPD) or continuous use of home oxygen or oral steroids
  • Acute myocardial infarction (AMI) within 30 days of SSC determination of eligibility
  • Leukopenia, chronic anemia (Hgb < 9 g/dL), current thrombocytopenia (platelets <70/mcL), history of bleeding diathesis, or coagulopathy
  • Unwilling to receive blood products
  • Deep vein thrombosis and/or pulmonary embolism in the last 6-months

Study Design

Enrollment

730 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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).

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).

Primary outcome measure

  • Composite of major adverse events (MAEs) [ Time Frame: 30 days post-procedure ]
  • Composite of all-cause mortality, heart failure hospitalization, or non-elective tricuspid valve reintervention [ Time Frame: 12 months post-procedure ]
  • Change in Quality of Life (QOL) as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: 12 months post procedure ]
  • Change in Quality of Life (QOL) as measured by New York Heart Association (NYHA) [ Time Frame: 12 months post procedure ]

Central Contacts and Locations

Central contacts

Vinny Podichetty

763-777-5969vpodichetty@vdyne.com

Jeya Satheesh

952-686-8158jsatheesh@vdyne.com

Locations

Minneapolis Heart Institute Foundation

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Nikki Clinical Research Manager

6128636286nikki.degeneffe@allina.com

Principal Investigator:

Konstantinos Voudris

More Information

Sponsor

VDyne, Inc.

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Keywords

  • VDyne
  • TRIVITA
  • TRIVITA Pivotal
  • Tricuspid Regurgitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VDyne, Inc. on 2026-08-17.