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VDyne System for Severe Tricuspid Regurgitation

This study is testing the VDyne Transcatheter Tricuspid Valve Replacement System for people with severe tricuspid regurgitation (a condition where the heart's tricuspid valve leaks). The VDyne System is a new device that replaces the leaky valve. You might be able to join if you have severe tricuspid regurgitation, experience symptoms (NYHA class II or higher), and have been treated with heart failure medications for at least 30 days. The study will look at how safe the VDyne System is (major adverse events within 30 days) and how well it improves your tricuspid regurgitation and symptoms (NYHA class) one month after the procedure. The study plans to enroll 30 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 30 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study measures outcomes up to one month after the procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05848284

Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation ( VISTA-US)

Recruiting
NAAges 18+InterventionalTreatment
VDyne, Inc.
~30 participants
Updated 2026-03-31 on ClinicalTrials.gov
What's tested:VDyne Transcatheter Tricuspid Valve Replacement System

At a glance

Recruiting sites
11 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The percentage of subjects with Device- and/or Procedure-related Major Adverse Events (MAE) within 30 days of the procedure, as classified by the Clinical Events Committee (CEC).
Measured over Implant to 30 days post-procedure
+4 more outcomes measured

Conditions

Tricuspid Regurgitation
Tricuspid Valve Disease
Tricuspid Valvular Disorders

Explore related trials

Tricuspid Valve Insufficiency

NCT05848284

Where you'd take part

This study runs at 11 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Ascension St. Thomas

    Nashville, Tennesseestudy coordinator listed

    Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, Californiastudy coordinator listed

    Recruiting

  • Columbia University Medical Center/NYPH

    New York, New Yorkstudy coordinator listed

    Recruiting

  • Henry Ford Hospital

    Detriot, Michiganstudy coordinator listed

    Recruiting

  • Mayo Clinic - Rochester

    Rochester, Minnesotastudy coordinator listed

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolinastudy coordinator listed

    Recruiting

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesotastudy coordinator listed

    Recruiting

  • Montefiore Medical Center

    The Bronx, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Vinny Podichetty
[email protected]
763-777-5969
Email the study team

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Eligibility criteria

Inclusion

Symptomatic severe tricuspid valve regurgitation of primary or secondary etiology.
NYHA class ≥ II. If NYHA Class IV, patient must be ambulatory.
Subject is adequately treated with medical therapy for heart failure ≥ 30 days prior to
index procedure, including a diuretic.
Heart Team determines patient is a recommended candidate for the VDyne System.
Age \>18 years at time of index procedure.
Clinical Screening Committee (CSC) and Imaging Core Labs confirm suitability for treatment with the VDyne System.

Exclusion

Patient anatomy (cardiac and vascular) is not suitable for VDyne System as assessed by Imaging Core Labs, Sponsor or Clinical Screening Committee (CSC)
Intolerance to procedural anticoagulation or post-procedural antiplatelet/ anticoagulation regimen that cannot be medically managed
Hypersensitivity to nickel or titanium
Left Ventricular Ejection Fraction (LVEF) \<30%.
Severe RV dysfunction.
Significant abnormalities of the tricuspid valve and sub-valvular apparatus.
Sepsis including active infective endocarditis (IE) (within last 6 months).
Right ventricular, atrial thrombus, vegetation or mass on tricuspid valve.
Severe tricuspid annular or leaflets calcification.
Systolic pulmonary hypertension with systolic pulmonary artery pressure \>70 mmHg.
History or rheumatic fever
Significant coronary artery disease requiring treatment such as symptomatic, unresolved multi-vessel or unprotected left main coronary artery disease.
Any planned surgery or interventional procedure within 30 days prior to or 30 days following the implant procedure. This includes any planned concomitant cardiovascular procedure such as CABG, PCI, pulmonary vein ablation, left atrial appendage occlusion, septal defect repair, etc.
Unresolved severe symptomatic carotid stenosis (\> 70% by ultrasound).
Cardiac resynchronization therapy device or implantable pulse generator implanted within 60 days of planned implant procedure.
Permanent pacing leads that will interfere with delivery or implantation of the VDyne Valve.
Cardiogenic shock or hemodynamic instability requiring inotropes or mechanical support devices at the time of planned implant procedure.
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.).
Significant valvular heart disease requiring intervention other than the tricuspid valve.
Known significant intracardiac shunt (e.g. septal defect)
Cerebrovascular accident (stroke, TIA) within 6 months of treatment procedure.
Severe lung disease (severe COPD or continuous use of home oxygen or oral steroids).
Acute myocardial infarction (AMI) within 30 days.
Significant renal dysfunction (eGFR\<30 ml/min/1.73m2) or on dialysis.
End-stage liver disease (MELD \> 11 / CHILD class C).
Bleeding requiring transfusion within prior 30 days.
Coagulopathy or other clotting disorder that cannot be medically managed.
Chronic immunosuppression or other condition that could impair healing response.
Any of the following: leukopenia, chronic anemia (Hgb \< 9), thrombocytopenia, history of bleeding diathesis, or coagulopathy.
Unwilling to receive blood products.
Known hypersensitivity or contraindication to procedural or post-procedural medications (e.g., contrast solution) which cannot be adequately managed medically.
Life expectancy less than 12 months due to non-cardiac comorbidities.
Treatment is not expected to provide benefit (futile).
Current IV Drug user (must be free drug abuse for \> 1 year).
Pregnant, lactating or planning pregnancy within next 12 months.
Vulnerable patient groups (minors, cognitively impaired persons, prisoners, persons whose willingness to volunteer could be unduly influenced by the expectation of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate, such as students, residents, and employees).
Currently participating in an investigational drug or device trial that has not reached its primary endpoint or is likely to interfere with this study.
Patient (or legal guardian) unable or unwilling to provide written, informed consent before study enrollment.
Patient unable or unwilling to comply with study required testing and follow-up visits

What this trial measures

  • The percentage of subjects with Device- and/or Procedure-related Major Adverse Events (MAE) within 30 days of the procedure, as classified by the Clinical Events Committee (CEC).Implant to 30 days post-procedure

    The percentage of subjects with Device- and/or Procedure-related Major Adverse Events (MAE) within 30 days of the procedure, as classified by the Clinical Events Committee (CEC).

  • Change in tricuspid valve regurgitation compared to baseline as measured by the Imaging Core LabsBaseline to 1 month after implant

    Change in tricuspid valve regurgitation compared to baseline as measured by the Imaging Core Labs

  • Changes in symptom status (NYHA class)Baseline to 1 month after implant

    Changes in symptom status (NYHA class)

  • Changes in functional capacity (6-minute walk test)Baseline to 1 month after implant

    Changes in functional capacity (6-minute walk test)

  • Changes in in quality of life (KCCQ score)Baseline to 1 month after implant

    Changes in in quality of life (KCCQ score). A higher score indicates worsening quality of life outcomes