RecruitingNot Applicable

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

Australia, Austria, Belgium120 participantsStarted 2023-03-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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%

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 30 days post-procedure

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

Timeframe: From Baseline to 1 month post-procedure

Changes in quality of life as measured by the KCCQ changes.

Timeframe: From Baseline to 1 month post-procedure

Changes in functional capacity (6-minute walk test)

Timeframe: From Baseline to 1 month post-procedure

Changes in symptom status (NYHA class)

Timeframe: From Baseline to 1 month post-procedure

Trial details

NCT IDNCT05797519

SponsorVDyne, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-30

Contact for this trial

Vinny Podichetty

+1.763.777.5969 vpodichetty@vdyne.com

View on ClinicalTrials.gov More Tricuspid Regurgitation trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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%

What they're measuring

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

Timeframe: 30 days post-procedure

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

Timeframe: From Baseline to 1 month post-procedure

Changes in quality of life as measured by the KCCQ changes.

Timeframe: From Baseline to 1 month post-procedure

Changes in functional capacity (6-minute walk test)

Timeframe: From Baseline to 1 month post-procedure

Changes in symptom status (NYHA class)

Timeframe: From Baseline to 1 month post-procedure