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

The purpose of this clinical study is to evaluate the safety and clinical efficacy of the VDyne System in the treatment of moderate to severe tricuspid regurgitation (TR).

Study Overview

• Status: Recruiting
• Conditions: Tricuspid Regurgitation; Tricuspid Valve Disease; Tricuspid Valvular Disorders
• Intervention / Treatment: Device: VDyne Transcatheter Tricuspid Valve Replacement System

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Laura Moffett; Phone Number: +1.952.303.2821; Email: lmoffett@vdyne.com
• Study Contact Backup: Name: Pree Bassi; Phone Number: +1-612-438-6888; Email: pbassi@vdyne.com

Study Locations

• Australia
  • Adelaide, Australia
    • Recruiting
    • Flinders Medical Centre
    • Contact: Rhys Hamson; Phone Number: 08 8204 5382; Email: Rhys.Hamson@sa.gov.au
    • Principal Investigator: Ajay Sinhal, MD
    • Principal Investigator: Jayme Bennetts
  • Brisbane, Australia
    • Recruiting
    • Princess Alexandra Hospital
    • Principal Investigator: Anthony Camuglia, MD
    • Contact: Katrina Brosnan; Email: Katrina.brosnan@health.qld.gov.au
  • Brisbane, Australia
    • Recruiting
    • The Prince Charles Hospital
    • Contact: Maricel Roxas; Phone Number: 07 31395906; Email: maricel.roxas@health.qld.gov.au
    • Principal Investigator: Darren Walters, MD
  • Melbourne, Australia
    • Recruiting
    • Monash Heart
    • Contact: Alexandra Jackson; Email: Alexandra.Jackson@monashhealth.org
  • New South Wales
    • Sydney, New South Wales, Australia, 2010
      • Recruiting
      • St. Vincent Hospital
      • Contact: Erika O'Dea; Phone Number: +61 2 8382 2775; Email: Erika.odea@svha.org.au
• Austria
  • Linz, Austria
    • Recruiting
    • Johannes Kepler University Linz - JKU
    • Contact: Jörg Kellermair, MD; Email: joerg_kellermair@hotmail.com
    • Principal Investigator: Andreas Zierer, MD
• Czechia
  • Prague, Czechia, 15030
    • Recruiting
    • Na Homolce Hospital
    • Contact: Petr Moucka, Mgr.; Phone Number: +420 257 272 392; Email: Petr.Moucka@homolka.cz
  • Trinec, Czechia
    • Recruiting
    • Nemocnice AGEL Podlesi Trinec
    • Contact: Miroslav Hudec; Email: miro.hudy@seznam.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Moderate or severe tricuspid valve regurgitation of primary or secondary etiology.
2. Subject is adequately treated with medical therapy for heart failure 30 days prior to index procedure, including a diuretic.
3. Heart Team determines patient is a recommended candidate for the VDyne System.
4. Age 18 years or older.
5. 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
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
6. Significant abnormalities of the tricuspid valve and sub-valvular apparatus.
7. Sepsis including active infective endocarditis (IE) (within last 6 months)
8. Right ventricular or atrial thrombus or vegetation
9. Severe tricuspid annular or leaflets calcification

10. Systolic pulmonary hypertension with systolic pulmonary artery pressure ≥70 mmHg.

    CONCOMITANT PROCEDURES

11. Significant coronary artery disease requiring treatment such as symptomatic, unresolved multi-vessel or unprotected left main coronary artery disease.
12. Any planned surgery or interventional procedure within the period of 30 days prior to 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
13. Unresolved severe symptomatic carotid stenosis (> 70% by ultrasound)
14. Cardiac resynchronization therapy device or implantable pulse generator implanted within 60 days of planned implant procedure.
15. Permanent pacing leads that will interfere with delivery or implantation of the VDyne Valve.
16. Cardiogenic shock or hemodynamic instability requiring inotropes or mechanical support devices at the time of planned implant procedure
17. Prior tricuspid valve surgery or catheter-based therapy with permanent residual devices implanted that would preclude delivery or implantation of the VDyne Valve (e.g. valve replacement, edge to edge repair.)
18. Severe valvular heart disease requiring intervention other than the tricuspid valve

19. Known significant intracardiac shunt (e.g. septal defect) (PFO's without significant shunts are allowed)

    COMORBIDITIES

20. Cerebrovascular accident (stroke, TIA) within 6 months of treatment procedure
21. Severe lung disease (severe COPD or continuous use of home oxygen or oral steroids)
22. Acute myocardial infarction (AMI) within 30 days
23. Significant renal dysfunction (eGFR<30 ml/min/1.73m2) or on dialysis
24. End-stage liver disease (MELD > 11 / CHILD class C)
25. Bleeding requiring transfusion within 30 days
26. Coagulopathy or other clotting disorder that cannot be medically managed
27. Chronic immunosuppression or other condition that could impair healing response
28. Any of the following: leukopenia, chronic anemia (Hgb < 9), thrombocytopenia, history of bleeding diathesis, or coagulopathy

29. Unwilling to receive blood products

    GENERAL EXCLUSION CRITERIA

30. Known hypersensitivity or contraindication to procedural or post-procedural medications (e.g., contrast solution) which cannot be adequately managed medically
31. Life expectancy less than 12 months due to non-cardiac comorbidities
32. Treatment is not expected to provide benefit (futile)
33. Current IV Drug user (must be free drug abuse for > 1 year)
34. Pregnant, lactating or planning pregnancy within next 12 months. (Female of child-bearing potential use two reliable contraceptive methods during the study - hormonal methods such as pill and condom).
35. 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)
36. Currently participating in an investigational drug or device trial that has not reached its primary endpoint or is likely to interfere with this study
37. Patient (or legal guardian) unable or unwilling to provide written informed consent before study-specific procedures are conducted
38. Patient unable or unwilling to comply with study required testing and follow-up visits.
39. Rhuematic fever

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

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
Mortality	Mortality will be reported at 30 days post-procedure	30 days post-procedure
Procedural success	Rate of successful implantation of the VDyne Valve using the VDyne Delivery System & freedom from serious device and/or procedure-related adverse events	From implant start time to procedure room exit
The percentage of subjects with Device- and/or Procedure-related Major Adverse Events (MAE)	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
Device success	Rate of successful implantation of the VDyne Valve using the VDyne Delivery System	From implant start time to procedure room exit
Change in tricuspid valve regurgitation as measured by the Imaging Core Labs	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.	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)	Changes in functional capacity (6-minute walk test)	From Baseline to 1 month post-procedure
Changes in symptom status (NYHA class)	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)	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	Change in tricuspid valve regurgitation as measured by the Imaging Core Lab	From Baseline to 3 months, 6 months and 1 year
Rate of heart failure hospitalization	Rate of heart failure hospitalization	From Baseline to 3 months, 6 months and 1 year
Changes in symptom status (NYHA class)	Changes in symptom status (NYHA class)	From Baseline to 3 months, 6 months and 1 year
Changes in functional capacity (6 minute walk test)	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.	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

Collaborators and Investigators

• Sponsor: VDyne, Inc.
• Investigators: Study Director: Laura Moffett, VDyne, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): September 30, 2029

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): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 27, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• 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