Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

67mo left

Started Apr 2024

Longer than P75 for not_applicable

Geographic Reach

2 countries

11 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7.7 years study duration

Study Progress27%

Apr 2024Nov 2031

First Submitted

Initial submission to the registry

March 29, 2023

Completed

1 month until next milestone

First Posted

Study publicly available on registry

May 8, 2023

Completed

11 months until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed

2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected

5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2031

Last Updated

March 31, 2026

Status Verified

February 1, 2026

Enrollment Period

2.7 years

First QC Date

March 29, 2023

Last Update Submit

March 25, 2026

Conditions

Tricuspid Regurgitation Tricuspid Valve Disease Tricuspid Valvular Disorders

Keywords

VDyne

Outcome Measures

Primary Outcomes (5)

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).
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
Change in tricuspid valve regurgitation compared to baseline as measured by the Imaging Core Labs
Change in tricuspid valve regurgitation compared to baseline as measured by the Imaging Core Labs
Baseline to 1 month after implant
Changes in symptom status (NYHA class)
Changes in symptom status (NYHA class)
Baseline to 1 month after implant
Changes in functional capacity (6-minute walk test)
Changes in functional capacity (6-minute walk test)
Baseline to 1 month after implant
Changes in in quality of life (KCCQ score)
Changes in in quality of life (KCCQ score). A higher score indicates worsening quality of life outcomes
Baseline to 1 month after implant

Secondary Outcomes (7)

The percentage of subjects with Device- and/or Procedure-related Major Adverse Events (MAE) after 30 days to 1 year of the procedure, as classified by the Clinical Events Committee (CEC).
30 days post-procedure to 1 year
Change in tricuspid valve regurgitation compared to baseline as measured by the Imaging Core Labs
1 month after implant to 1 year post-implant
Changes in right ventricle as measured by core lab
1 month after implant to 1 year post-implant
Rate of heart failure hospitalization
1 month after implant to 1 year post-implant
Changes in symptom status (NYHA class)
1 month after implant to 1 year post-implant
+2 more secondary outcomes

Study Arms (1)

VDyne System Treatment Arm

EXPERIMENTAL

Device

Device: VDyne Transcatheter Tricuspid Valve Replacement System

Interventions

VDyne Transcatheter Tricuspid Valve Replacement SystemDEVICE

The study investigational device is the VDyne Transcatheter Tricuspid Valve Replacement System which consists of a bioprosthetic implantable tricuspid valve, the VDyne Delivery System, Drop Tether, accessories that facilitate the placement of the valve and the VDyne Retrieval System. The VDyne Valve is deployed by transfemoral implantation within the native tricuspid valve and is implanted under fluoroscopic and transesophageal echocardiography (TEE) guidance, while the heart remains beating, without the use of CPB. The valve is repositionable and fully retrievable intraoperatively. Repositioning allows optimization of the valve position following deployment, and retrieval, with the VDyne Retrieval System, allows use of an alternative valve size or removal of the index VDyne Valve in the event of suboptimal valve delivery or other intraoperative complication.

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

VDyne System Treatment Arm

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.
+24 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

VDyne, Inc.lead

Study Sites (11)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Henry Ford Hospital

Detriot, Michigan, 48208, United States

RECRUITING

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

RECRUITING

Mayo Clinic - Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Columbia University Medical Center/NYPH

New York, New York, 10032, United States

RECRUITING

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

The Christ Hospital

Cincinnati, Ohio, 45219, United States

RECRUITING

Oregon Health and Science Unversity

Portland, Oregon, 97239, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Ascension St. Thomas

Nashville, Tennessee, 37205, United States

RECRUITING

Québec-Université Laval (IUCPQ-ULaval)

Québec, Quebec, G1V 4G5, Canada

RECRUITING

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Central Study Contacts

Vinny Podichetty

CONTACT

763-777-5969 vpodichetty@vdyne.com

Jeya Satheesh

CONTACT

952-686-8158 jsatheesh@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 29, 2023

First Posted

May 8, 2023

Study Start

April 1, 2024

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2031

Last Updated

March 31, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing: Will not share

Locations

CA(1)US(10)

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

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (5)

Secondary Outcomes (7)

Study Arms (1)

VDyne System Treatment Arm

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (11)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (5)

Secondary Outcomes (7)

Study Arms (1)

VDyne System Treatment Arm

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (11)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations