Vyne TriNova Transcatheter Tricuspid Valve Replacement study for severe tricuspid regurgitation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multi-center randomized pivotal trial comparing the VDyne TriNova Transcatheter Tricuspid Valve Replacement system to the Edwards EVOQUE system in adults with symptomatic severe or greater tricuspid regurgitation. Participants will be followed from discharge through 30 days, 3 months, 6 months, and yearly for up to 5 years to assess safety and effectiveness. Eligibility includes NYHA class II–IV symptoms, prior adequate medical therapy, and a heart team deeming transcatheter replacement appropriate. Exclusion criteria include inability to comply with testing, participation in conflicting trials, and pregnancy or lactation. Lead sponsor is VDyne, Inc., with sites in Arizona and California.

Why it matters

Who can join: the full rules

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

Where it's running

• Banner Health
  Phoenix, Arizona, United States Recruiting
• Honor Health
  Scottsdale, Arizona, United States Recruiting
• Sutter Health/ California Pacific Medical Center
  San Francisco, California, United States Recruiting
• Kaiser Permanente San Francisco
  San Francisco, California, United States Recruiting
• Ascension Via Christi Hospital
  Wichita, Kansas, United States Recruiting
• Henry Ford Hospital
  Detriot, Michigan, United States Recruiting

Study contacts

• Principal investigator: Brian O'Neill, MD — Henry Ford Health System
• Study coordinator: Vinny Podichetty
• Email: vpodichetty@vdyne.com
• Phone: 763-777-5969

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Transcatheter Tricuspid Valve Replacement for Severe Tricuspid Regurgitation

  This trial tests the Laplace TTVR System to see if it safely and effectively treats adults with severe tricuspid regurgitation.

  Recruiting at 2 sites Laplace Interventional, Inc · Tulsa, Oklahoma and 1 other locations · NCT07687485

• TruGamma tricuspid valve replacement for high-risk patients

  This trial tests the TruGamma tricuspid valve replacement system in high-risk patients with severe tricuspid regurgitation to see if it is safe and helps symptoms when added to standard medical care.

  Recruiting Jiangsu Trulive Medical Co., Ltd · Beijing, Beijing Municipality · NCT07691307

• Investigating multiple and mixed heart valve diseases

  This study looks at how common different types of heart valve diseases are and their features by gathering information from patients around the world who have been diagnosed with these conditions.

  Recruiting Assistance Publique - Hôpitaux de Paris · Paris, Île-de-France Region · NCT06235385

• Evaluating the DUO System for treating Tricuspid Regurgitation

  This study is testing a new heart valve system to see if it can help people with severe tricuspid regurgitation feel better and improve their heart function.

  Recruiting at 17 sites CroiValve Limited · Phoenix, Arizona and 17 other locations · NCT05913908

• TRIFORMIS RESILIA heart valve real-world results in tricuspid disease

  A real-world, observational study to see how the Edwards TRIFORMIS RESILIA tricuspid heart valve performs in adults needing tricuspid valve replacement.

  Recruiting Edwards Lifesciences · Carmel, Indiana · NCT07684313

• Tracking progression and consequences of heart valve disease

  This project will follow adults with moderate or worse valve disease to see if clinical tests and imaging can predict when their condition will get worse.

  Recruiting at 15 sites Second Affiliated Hospital, Zhejiang University, School of Medicine · Fuzhou, Fujian and 14 other locations · NCT07267117

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.