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

October 30, 2025 updated by: VDyne, Inc.
The purpose of this clinical study is to collect safety and efficacy data of the VDyne System to support Conformitè Europëenne (CE) Mark of the VDyne System.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
      • Adelaide, Australia
        • Recruiting
        • Flinders Medical Centre
        • Contact:
        • Principal Investigator:
          • Ajay Sinhal, MD
        • Principal Investigator:
          • Jayme Bennetts
      • Brisbane, Australia
      • Brisbane, Australia
        • Recruiting
        • The Prince Charles Hospital
        • Contact:
        • Principal Investigator:
          • Darren Walters, MD
      • Melbourne, Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2010
        • Recruiting
        • St. Vincent Hospital
        • Contact:
  • Austria
      • Linz, Austria
        • Recruiting
        • Johannes Kepler University Linz - JKU
        • Contact:
        • Principal Investigator:
          • Andreas Zierer, MD
      • Vienna, Austria, 1090
  • Belgium
      • Bruges, Belgium
  • Czechia
      • Třinec, Czechia
  • Denmark
      • Copenhagen, Denmark, DK-2100
        • Recruiting
        • University Hospital of Copenhagen
        • Contact:
        • Principal Investigator:
          • Ole De Baker
  • Germany
      • Bad Oeynhausen, Germany
        • Recruiting
        • Herz & Diabeteszentrum Nordrhein Westfalen
        • Contact:
        • Principal Investigator:
          • Volker Rudolph
      • Berlin, Germany, 10967
        • Recruiting
        • Vivantes Klinik Am Urban
        • Contact:
      • Kiel, Germany, 24105
        • Recruiting
        • Universitätsklinikum Schleswig-Holstein, Campus Kiel
        • Contact:
      • Rostock, Germany, 18057
        • Recruiting
        • Universitätsmedizin Rostock
        • Contact:
  • Netherlands
      • Nieuwegein, Netherlands
        • Recruiting
        • St Antonius Hospital
        • Contact:
        • Principal Investigator:
          • Martin Swaans
  • New Zealand
    • Hamilton
  • Spain
  • Sweden
      • Lund, Sweden
        • Recruiting
        • Lund University Skåne University Hospital
        • Contact:
        • Contact:
  • United Kingdom
      • London, United Kingdom
        • Recruiting
        • Royal Brompton Hospital
        • Principal Investigator:
          • Alison Duncan
        • Contact:
    • Sussex
      • Brighton, Sussex, United Kingdom, BN2 1ES
        • Recruiting
        • Royal Sussex Hospital
        • Principal Investigator:
          • David Hildick-Smith
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

VDYNE SYSTEM SUITABILITY

  1. Patient anatomy (cardiac and vascular) is not suitable for the VDyne System as assessed by Imaging Core Labs, Sponsor and/or Clinical Screening Committee (CSC)
  2. Intolerance to procedural anticoagulation or post-procedural antiplatelet/anticoagulation regimen that cannot be medically managed

  3. Hypersensitivity to nickel or titanium

    CLINICAL EXCLUSION CRITERIA (assessed by pre-procedural imaging)

  4. Left Ventricular Ejection Fraction (LVEF) <30%
  5. Severe RV dysfunction as assessed by the Clinical Screening Committee (CSC).
  6. Significant abnormalities of the tricuspid valve and sub-valvular apparatus
  7. Sepsis including active infective endocarditis (IE) (within the last 6 months)
  8. Right ventricular, atrial thrombus, vegetation or mass on tricuspid valve.
  9. Severe tricuspid annular or leaflets calcification
  10. Systolic pulmonary hypertension with systolic pulmonary artery pressure >70 mmHg or pulmonary vascular resistance (PVR) >5 wood units as determined by RHC.

  11. History of rheumatic fever that impacts the native tricuspid valve or surrounding structures.

    CONCOMITANT PROCEDURES

  12. Significant coronary artery disease requiring treatment such as symptomatic, unresolved multi-vessel or unprotected left main coronary artery disease (CAD).
  13. Any planned surgery or interventional procedure within 30 days prior to or following the implant procedure. This includes any planned concomitant cardiovascular procedure [e.g. Coronary Artery Bypass Grafting (CABG), percutaneous coronary intervention (PCI), pulmonary vein ablation, left atrial appendage occlusion, septal defect repair, etc.]
  14. Unresolved severe symptomatic carotid stenosis (> 70% by ultrasound)
  15. Cardiac resynchronization therapy device or implantable pulse generator implanted within 60 days of planned implant procedure.
  16. Permanent pacing leads that will interfere with delivery or implantation of the VDyne Valve.
  17. Cardiogenic shock or hemodynamic instability requiring inotropes or mechanical support devices at the time of planned implant procedure.
  18. 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.)
  19. Significant valvular heart disease requiring intervention other than the tricuspid valve

  20. Known significant intracardiac shunt [e.g. septal defect), patent foramen ovales (PFOs) without significant shunts are allowed]

    COMORBIDITIES

  21. Cerebrovascular accident (stroke, TIA) within 6 months of treatment procedure
  22. Severe lung disease [severe chronic obstructive pulmonary disease (COPD) or continuous use of home oxygen or oral steroids]
  23. Acute myocardial infarction (AMI) within 30 days
  24. Significant renal dysfunction (eGFR<30 ml/min/1.73m2) or on dialysis
  25. End-stage liver disease (MELD > 11 and Child-Pugh class C)
  26. Bleeding requiring transfusion within 30 days
  27. Coagulopathy or other clotting disorder that cannot be medically managed
  28. Chronic immunosuppression or other condition that could impair healing response
  29. Any of the following: leukopenia, chronic anemia [Hemoglobin (Hgb) < 9], current thrombocytopenia (platelets <70), history of bleeding diathesis, or coagulopathy
  30. Unwilling to receive blood products GENERAL EXCLUSION CRITERIA
  31. Known hypersensitivity or contraindication to procedural or post-procedural medications (e.g., contrast solution) which cannot be adequately managed medically
  32. Life expectancy less than 12 months due to non-cardiac comorbidities
  33. Treatment is not expected to provide benefit (futile)
  34. Current IV Drug user (must be free drug abuse for > 1 year)
  35. Pregnant, lactating or planning pregnancy during the course of the study
  36. 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)
  37. Currently participating in an investigational drug or device trial that has not reached its primary endpoint or is likely to interfere with this study
  38. Patient (or legal guardian) unable or unwilling to provide written informed consent before study-specific procedures are conducted
  39. Patient unable or unwilling to comply with study required testing and follow-up visits.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VDyne System Treatment Arm
Device: VDyne Transcatheter Tricuspid Valve Replacement System
The study investigational device is the VDyne Transcatheter Tricuspid Valve Replacement System.
Other Names:
  • VDyne System
  • VDyne Tricuspid System
  • VDyne Valve System
  • VDyne Valve

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The percentage of subjects with Device- and/or Procedure-related Major Adverse Events (MAE)
Time Frame: 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).
30 days post-procedure
Change in tricuspid valve regurgitation as measured by the Imaging Core Labs
Time Frame: From Baseline to 1 month post-procedure
Change in tricuspid valve regurgitation as measured by the Imaging Core Labs
From Baseline to 1 month post-procedure
Changes in quality of life as measured by the KCCQ changes.
Time Frame: From Baseline to 1 month post-procedure
Changes in quality of life as measured by the KCCQ changes. Higher score indicates worse outcome.
From Baseline to 1 month post-procedure
Changes in functional capacity (6-minute walk test)
Time Frame: From Baseline to 1 month post-procedure
Changes in functional capacity (6-minute walk test)
From Baseline to 1 month post-procedure
Changes in symptom status (NYHA class)
Time Frame: From Baseline to 1 month post-procedure
Changes in symptom status (NYHA class)
From Baseline to 1 month post-procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The percentage of subjects with Device- and/or Procedure-related Major Adverse Events (MAE)
Time Frame: From Baseline to 1 year post-procedure
The percentage of subjects with Device- and/or Procedure related Major Adverse Events as classified by the CEC
From Baseline to 1 year post-procedure
Change in tricuspid valve regurgitation as measured by the Imaging Core Lab
Time Frame: From Baseline to 3 months, 6 months and 1 year
Change in tricuspid valve regurgitation as measured by the Imaging Core Lab
From Baseline to 3 months, 6 months and 1 year
Changes in symptom status (NYHA class)
Time Frame: From Baseline to 3 months, 6 months and 1 year
Changes in symptom status (NYHA class)
From Baseline to 3 months, 6 months and 1 year
Changes in functional capacity (6 minute walk test)
Time Frame: From Baseline to 3 months, 6 months and 1 year
Changes in functional capacity (6 minute walk test)
From Baseline to 3 months, 6 months and 1 year
Changes in quality of life as measured by the KCCQ changes.
Time Frame: From Baseline to 3 months, 6 months and 1 year
Changes in quality of life as measured by the KCCQ changes. Higher score indicates worse outcome.
From Baseline to 3 months, 6 months and 1 year
Intra-Procedural success
Time Frame: From implant start time to procedure room exit
Rate of successful implantation of the VDyne Valve using the VDyne Delivery System, absence of procedural mortality or stroke, adequate performance of the VDyne Valve, no device-related obstruction of forward flow or pulmonary embolism and & freedom from emergency surgery or reintervention during the first 24 hours related to the device or access procedure.
From implant start time to procedure room exit
Clinical success
Time Frame: From implant to 30 days post implant
Absence of procedural mortality, proper position of the device with adequate performance, freedom from unplanned surgical or interventional procedures related to the device or procedure, absence of major adverse events, device related pulmonary embolism and obstruction of forward flow, any severe hemodynamic compromise leading to heart transplantation or major cardiac assistance or any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention.
From implant to 30 days post implant
Clinical success
Time Frame: From implant to 1 Year post-implant
No rehospitalizations or reinterventions for the underlying condition (e.g., tricuspid regurgitation/stenosis, heart failure);
From implant to 1 Year post-implant
Clinical success
Time Frame: From implant to 1 Year post-implant
Improvement from baseline in symptoms (e.g., NYHA improvement by >1 functional class); and/or Improvement from baseline in functional status (e.g., 6-min walk test improvement by >30 m); and/or Improvement from baseline in quality-of-life (e.g., Kansas City Cardiomyopathy Questionnaire improvement by >10)
From implant to 1 Year post-implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VDyne, Inc.

Investigators

  • Study Director: Vinny Podichetty, VDyne, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2030

Study Registration Dates

First Submitted

March 6, 2023

First Submitted That Met QC Criteria

March 21, 2023

First Posted (Actual)

April 4, 2023

Study Record Updates

Last Update Posted (Estimated)

November 3, 2025

Last Update Submitted That Met QC Criteria

October 30, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TPR0038-P

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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