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

NCT05797519 | Recruiting DMC FDA Device

• 1 other identifier: TPR0038-P
• Study Type: interventional
• Target: 120
• Locations: 10 countries
• Sites: 19

Brief Summary

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.

Conditions

Tricuspid Regurgitation; Tricuspid Valve Disease; Tricuspid Valvular Disorders

Outcome Measures

Primary Outcomes (5)

• 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

• 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 Outcomes (9)

• The percentage of subjects with Device- and/or Procedure-related Major Adverse Events (MAE)

  From Baseline to 1 year post-procedure

• Change in tricuspid valve regurgitation as measured by the Imaging Core Lab

  From Baseline to 3 months, 6 months and 1 year

• Intra-Procedural success

  From implant start time to procedure room exit

• Clinical success

  From implant to 30 days post implant

• Changes in symptom status (NYHA class)

  From Baseline to 3 months, 6 months and 1 year

Study Arms (1)

VDyne System Treatment Arm

EXPERIMENTAL

Device: VDyne Transcatheter Tricuspid Valve Replacement System

Interventions

VDyne Transcatheter Tricuspid Valve Replacement System DEVICE

The study investigational device is the VDyne Transcatheter Tricuspid Valve Replacement System.

Also known as: VDyne System, VDyne Tricuspid System, VDyne Valve System, VDyne Valve

VDyne System Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe or greater 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 or older at time of the index procedure.
• Clinical Screening Committee (CSC) and Imaging Core Labs confirm suitability for treatment with the VDyne System.

You may not qualify if:

• VDYNE SYSTEM SUITABILITY
• 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)
• 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 as assessed by the Clinical Screening Committee (CSC).
• Significant abnormalities of the tricuspid valve and sub-valvular apparatus
• Sepsis including active infective endocarditis (IE) (within the 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 or pulmonary vascular resistance (PVR) \>5 wood units as determined by RHC.
• History of rheumatic fever that impacts the native tricuspid valve or surrounding structures.
• CONCOMITANT PROCEDURES
• Significant coronary artery disease requiring treatment such as symptomatic, unresolved multi-vessel or unprotected left main coronary artery disease (CAD).
• Any planned surgery or interventional procedure within 30 days prior to or following the implant procedure. This includes any planned concomitant cardiovascular procedure \[e.g. Coronary Artery Bypass Grafting (CABG), percutaneous coronary intervention (PCI), pulmonary vein ablation, left atrial appendage occlusion, septal defect repair, etc.\]

Sponsors & Collaborators

• VDyne, Inc.: lead

Study Sites (21)

St. Vincent Hospital

Sydney, New South Wales, 2010, Australia

RECRUITING

Flinders Medical Centre

Adelaide, Australia

RECRUITING

Princess Alexandra Hospital

Brisbane, Australia

RECRUITING

The Prince Charles Hospital

Brisbane, Australia

RECRUITING

Monash Heart

Melbourne, Australia

RECRUITING

Johannes Kepler University Linz - JKU

Linz, Austria

RECRUITING

Universitätsklinik für Herzchirurgie Medizinische Universität Wien

Vienna, 1090, Austria

RECRUITING

AZ Sint Jan Hospital

Bruges, Belgium

RECRUITING

Nemocnice AGEL Podlesi Trinec

Třinec, Czechia

RECRUITING

University Hospital of Copenhagen

Copenhagen, DK-2100, Denmark

RECRUITING

Herz & Diabeteszentrum Nordrhein Westfalen

Bad Oeynhausen, Germany

RECRUITING

Vivantes Klinik Am Urban

Berlin, 10967, Germany

RECRUITING

Universitätsklinikum Schleswig-Holstein, Campus Kiel

Kiel, 24105, Germany

RECRUITING

Universitätsmedizin Rostock

Rostock, 18057, Germany

RECRUITING

St Antonius Hospital

Nieuwegein, Netherlands

RECRUITING

Waikato Hospital

Hamilton, Hamilton, 3204, New Zealand

RECRUITING

Hospital Universitario Puerta de Hierro

Madrid, 28222, Spain

RECRUITING

Hospital Clínico San Carlos

Madrid, Spain

RECRUITING

Lund University Skåne University Hospital

Lund, Sweden

RECRUITING

Royal Sussex Hospital

Brighton, Sussex, BN2 1ES, United Kingdom

RECRUITING

Royal Brompton Hospital

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Vinny Podichetty

  VDyne, Inc.

  STUDY DIRECTOR

Central Study Contacts

Vinny Podichetty

CONTACT

+1.763.777.5969; vpodichetty@vdyne.com

Pree Bassi

CONTACT

+1-612-438-6888; pbassi@vdyne.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: April 4, 2023
• Study Start: March 1, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2030
• Last Updated: November 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1); GB (2); AU (5); NL (1); ES (2); NZ (1); DE (4); BE (1); DK (1); SE (1)