VDyne Transcatheter Tricuspid Valve Replacement Study to Evaluate Safety and Clinical Efficacy in Patients With Symptomatic Severe Tricuspid Valve Regurgitation (TRIVITA Pivotal Trial) (TRIVITA)

March 31, 2026 updated by: VDyne, Inc.

VDyne Transcatheter Tricuspid Valve Replacement Study to Evaluate Safety and Clinical Efficacy in Patients With Symptomatic Severe Tricuspid Valve Regurgitation

Pivotal trial to evaluate the safety and clinical efficacy of the VDyne System for the treatment of symptomatic severe or greater tricuspid regurgitation.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The clinical trial is a prospective, multi-center, randomized controlled pivotal trial to evaluate the safety and effectiveness of the VDyne Transcatheter Tricuspid Valve Replacement (TTVR) System compared to Edwards EVOQUE TTVR System in symptomatic patients with severe or greater tricuspid regurgitation. Subjects will be followed at discharge, 30 days, 3 months, 6 months and annually through 5 years.

Study Type

Interventional

Enrollment (Estimated)

730

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

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥18 years old
  • Subject is willing and able to comply with all study evaluations and provide consent
  • Subject must agree not to participate in any other clinical trial for a period of one year following index procedure
  • New York Heart Association (NYHA) Functional Class II, III, or IV and ambulatory
  • At least severe symptomatic tricuspid regurgitation.
  • Despite adequate and Optimized Medical Therapy (OMT), subject has signs and symptoms from TR, or prior heart failure hospitalization from TR
  • Heart team determines that the subject is appropriate for transcatheter tricuspid valve replacement
  • Functional and/or degenerative TR graded as at least severe

Exclusion Criteria:

  • Subject unable or unwilling to comply with study required testing and follow-up visits
  • Subject is currently participating in another clinical trial (drug, biologic, or device) that has not yet completed its primary endpoint or is likely to interfere with this study
  • Pregnant, lactating subjects, and /or those who plan pregnancy in the period up to one year following index procedure.
  • Known hypersensitivity or contraindication to procedural or post-procedural medications (e.g., contrast solution, anticoagulation, etc.) which cannot be adequately managed medically
  • Life expectancy ≤12 months due to non-cardiac comorbidities
  • Current IV Drug user (must be free from drug abuse for ≥1 year)
  • Subject unable or unwilling to provide written, informed consent before study enrollment
  • Tricuspid valve anatomy (cardiac and vascular) that is not suitable for the VDyne System
  • Hypersensitivity to metals (such as nickel or titanium)
  • 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.)
  • Severe valvular heart disease using established echocardiographic criteria requiring intervention other than the tricuspid valve
  • Known significant intracardiac shunt (e.g., septal defect).
  • Cerebrovascular accident (stroke, TIA) within 90 days of treatment procedure
  • Severe lung disease (severe COPD) or continuous use of home oxygen or oral steroids
  • Acute myocardial infarction (AMI) within 30 days of SSC determination of eligibility
  • Leukopenia, chronic anemia (Hgb < 9 g/dL), current thrombocytopenia (platelets <70/mcL), history of bleeding diathesis, or coagulopathy
  • Unwilling to receive blood products
  • Deep vein thrombosis and/or pulmonary embolism in the last 6-months

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Randomized cohort VDyne TTVR
Transcatheter tricuspid valve replacement with VDyne System in patients with severe or greater tricuspid regurgitation.
Device: Transcatheter Tricuspid Valve Replacement (TTVR) with VDyne System
Subjects will undergo TTVR procedure with VDyne device and will continue to be managed on Optimal Medical Therapy (OMT).
Other Names:
  • Transcatheter Tricuspid Valve Replacement
Active Comparator: Randomized cohort Edwards EVOQUE TTVR
Transcatheter tricuspid valve replacement with Edwards EVOQUE System in patients with severe or greater tricuspid regurgitation.
Device: Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE System
Subjects will undergo TTVR procedure with Edwards EVOQUE device and will continue to be managed on Optimal Medical Therapy (OMT).
Other Names:
  • Transcatheter Tricuspid Valve Replacement
Experimental: Single Arm Registry
Transcatheter tricuspid valve replacement with VDyne System in patients with severe or greater tricuspid regurgitation who are deemed ineligible to be treated with Active Comparator EVOQUE device.
Device: Transcatheter Tricuspid Valve Replacement (TTVR) with VDyne System
Subjects will undergo TTVR procedure with VDyne device and will continue to be managed on Optimal Medical Therapy (OMT).
Other Names:
  • Transcatheter Tricuspid Valve Replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of major adverse events (MAEs)
Time Frame: 30 days post-procedure

Composite of major adverse events consist of the following:

  • Cardiovascular mortality
  • Stroke
  • Life-threatening bleeding
  • Major vascular complications
  • Major cardiac structural complications
  • Stage 2 or 3 acute kidney injury
  • Myocardial infarction or coronary ischemia
  • Device-related obstruction of forward flow
  • Device-related pulmonary embolism
  • Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention
30 days post-procedure
Composite of all-cause mortality, heart failure hospitalization, or non-elective tricuspid valve reintervention
Time Frame: 12 months post-procedure
All-cause mortality, heart failure hospitalization and non-elective tricuspid valve reintervention will be adjudicated by a Clinical Events Committee.
12 months post-procedure
Change in Quality of Life (QOL) as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame: 12 months post procedure
The Quality of Life KCCQ questionnaire is a measure of health-related quality of life. It is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life related to Heart Failure. From 23-items, the Overall Summary Score (OSS) will be calculated. In the OSS, each of the 23 items are converted onto a 0 to 100 scale using this formula: (Raw score - Minimum Raw Score)/(Maximum Raw Score - Minimum Raw Score) * 100. Then these are averaged across the 23 items. A score of 100 (the maximum score) would indicate maximum quality of life relating to heart failure and a score of 0 (scale minimum) would indicate the worst possible quality of life relating to heart failure, with higher scores generally indicating higher quality of life.
12 months post procedure
Change in Quality of Life (QOL) as measured by New York Heart Association (NYHA)
Time Frame: 12 months post procedure

The New York Heart Association (NYHA) Classification provides a way of classifying the extent of heart failure by classifying patients in one of four categories based on their limitations during physical activity and in degree of shortness of breath and or angina pain. Class I is the least severe and Class IV is the most severe. The classes are:

Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.

Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.

Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances. Comfortable only at rest.

Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.
12 months post procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-Cause Mortality
Time Frame: At 12 months and 24 months
Total number of deaths from any cause
At 12 months and 24 months
RVAD implantation or heart transplant
Time Frame: At 12 months and 24 months
Total number of patients requiring Right Ventricular Assist Device (RVAD) implantation or heart transplant
At 12 months and 24 months
Tricuspid valve surgical or percutaneous intervention
Time Frame: At 12 months and 24 months
Total number of non-elective tricuspid valve re-interventions
At 12 months and 24 months
Heart failure hospitalizations
Time Frame: At 12 months and 24 months
Total number of patients with at least one hospital admission due to heart failure
At 12 months and 24 months
Change in Quality of Life (QOL) as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame: At 12 months and 24 months
The Quality of Life KCCQ questionnaire is a measure of health-related quality of life. It is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life related to Heart Failure. From 23-items, the Overall Summary Score (OSS) will be calculated. In the OSS, each of the 23 items are converted onto a 0 to 100 scale using this formula: (Raw score - Minimum Raw Score)/(Maximum Raw Score - Minimum Raw Score) * 100. Then these are averaged across the 23 items. A score of 100 (the maximum score) would indicate maximum quality of life relating to heart failure and a score of 0 (scale minimum) would indicate the worst possible quality of life relating to heart failure, with higher scores generally indicating higher quality of life.
At 12 months and 24 months
Change in Quality of Life (QOL) as measured by New York Heart Association (NYHA)
Time Frame: 12 months

New York Heart Association (NYHA) Classification at 6 months. The New York Heart Association (NYHA) Classification provides a way of classifying the extent of heart failure by classifying patients in one of four categories based on their limitations during physical activity and in degree of shortness of breath and or angina pain. Class I is the least severe and Class IV is the most severe. The classes are:

Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.

Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.

Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances. Comfortable only at rest.

Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.
12 months
Change in 6-Minute Walk Distance (6MWD)
Time Frame: At 12 months and 24 months
Functional status improvement, as measured by 6-Minute Walk Test total distance walked. The 6-Minute Walk Test (6MWT) is a test that measures the total distance an individual can walk on a flat, hard surface in 6 minutes. It is commonly used to evaluate functional exercise capacity in patients with conditions including heart failure. The minimum score possible is 0, which would represent an inability to walk any distance. There is no maximum score, as a patient could theoretically walk any distance in 6 minutes though 800 meters considered the top reference range, which is what would be expected by elite athletes. Higher score indicate greater higher exercise capacity and lower scores indicate lower exercise capacity.
At 12 months and 24 months
Change in Echocardiographic Tricuspid Regurgitation (TR) grade from baseline using TransEsophageal Echocardiogram (TEE)
Time Frame: At 6 months, 12 months and 24 months post-implant compared to baseline
Change in Tricuspid Regurgitation (TR) grade from baseline is measured. A 5-tier grading scheme will be used: mild, moderate, severe, massive and torrential. The change in TR grade is assessed using TransEsophageal Echocardiogram (TEE) imaging.
At 6 months, 12 months and 24 months post-implant compared to baseline

Collaborators and Investigators

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

Sponsor

VDyne, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2036

Study Registration Dates

First Submitted

March 25, 2026

First Submitted That Met QC Criteria

March 31, 2026

First Posted (Actual)

April 8, 2026

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP-CL-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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