VDyne TriNova Transcatheter Tricuspid Valve Replacement Study to Evaluate Safety and Clinical Efficacy in Patients With Symptomatic Severe Tricuspid Valve Regurgitation (TRIVITA Pivotal Trial)
Tricuspid Valve Regurgitation · Tricuspid Valve Disease · Cardiovascular Diseases (CVD) · Heart Valve Diseases · Tricuspid Valve Insufficiency · Severe Heart Valve Disease · Randomized Controlled Trial (RCT) · Symptomatic Tricuspid Regurgitation
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 520 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
Pivotal trial to evaluate the safety and clinical efficacy of the VDyne TriNova System for the treatment of symptomatic severe or greater tricuspid regurgitation.
Read the full description
The clinical trial is a prospective, multi-center, randomized controlled pivotal trial to evaluate the safety and effectiveness of the VDyne TriNova 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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- Single masked
Randomized cohort VDyne TriNova TTVR
Transcatheter tricuspid valve replacement with VDyne TriNova System in patients with severe or greater tricuspid regurgitation.
Device: Transcatheter Tricuspid Valve Replacement (TTVR) with VDyne TriNova System
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
Single Arm Registry
Transcatheter tricuspid valve replacement with VDyne TriNova 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 TriNova System
Transcatheter Tricuspid Valve Replacement (TTVR) with VDyne TriNova System DEVICE
Subjects will undergo TTVR procedure with VDyne TriNova device and will continue to be managed on Optimal Medical Therapy (OMT).
Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE System DEVICE
Subjects will undergo TTVR procedure with Edwards EVOQUE device and will continue to be managed on Optimal Medical Therapy (OMT).
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Composite of major adverse events (MAEs)
Time frame: 30 days post-procedure
- Cardiovascular mortality
- Myocardial infarction
- All stroke
- New need for renal replacement therapy
- Severe bleeding
- Non-elective tricuspid valve re-intervention
- Major access site and vascular complications
- Major cardiac structural complications
- Device-related pulmonary embolism
- New arrhythmia or conduction disorder requiring permanent pacing
Composite of all-cause mortality, heart failure hospitalization, or non-elective tricuspid valve reintervention
Time frame: 12 months post-procedure
Not reported in this registry record.
Change in Quality of Life (QOL) as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: 12 months post-procedure
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.
Change in Quality of Life (QOL) as measured by New York Heart Association (NYHA)
Time frame: 12 months post-procedure
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.
Secondary measures
All-Cause Mortality
Time frame: At 12 months and 24 months
Total number of deaths from any cause
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
Tricuspid valve surgical or percutaneous intervention
Time frame: At 12 months and 24 months
Total number of non-elective tricuspid valve re-interventions
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
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.
Change in Echocardiographic Tricuspid Regurgitation (TR) grade from baseline using TransThoracic Echocardiogram (TTE)
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 TransThoracic Echocardiogram (TTE) imaging.
Change in Quality of Life (QOL) as measured by New York Heart Association (NYHA)
Time frame: 12 months post-procedure
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.
Change in Quality of Life (QOL) as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: 12 months post-procedure
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.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (12)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
12 locations
Banner HealthPhoenix, Arizona, United StatesRecruiting
Honor HealthScottsdale, Arizona, United StatesRecruiting
Sutter Health/ California Pacific Medical CenterSan Francisco, California, United StatesRecruiting
Kaiser Permanente San FranciscoSan Francisco, California, United StatesRecruiting
Ascension Via Christi HospitalWichita, Kansas, United StatesRecruiting
Henry Ford HospitalDetriot, Michigan, United StatesRecruiting
Minneapolis Heart InstituteMinneapolis, Minnesota, United StatesRecruiting
Mayo ClinicRochester, Minnesota, United StatesRecruiting
The Christ HospitalCincinnati, Ohio, United StatesRecruiting
Oregon Health and Science UnversityPortland, Oregon, United StatesRecruiting
Medical University of South CarolinaCharleston, South Carolina, United StatesRecruiting
Intermountain Medical CenterMurray, Utah, United StatesRecruiting
Study team and timeline
- Lead sponsor
- VDyne, Inc.
- Study start
- Jul 28, 2026 Actual
- Primary completion
- 2029-06 Estimated
- Study completion
- 2036-06 Estimated
- First posted
- Apr 8, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
VDyne Transcatheter Tricuspid Valve Replacement Study to Evaluate Safety and Clinical Efficacy in Patients With Symptomatic Severe Tricuspid Valve Regurgitation
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026