NCT07516444 · VDyne, Inc.
VDyne Transcatheter Tricuspid Valve Replacement Study to Evaluate Safety and Clinical Efficacy in Patients With Symptomatic Severe Tricuspid Valve Regurgitation (TRIVITA Pivotal Trial)
(TRIVITA)
What this study is about
Pivotal trial to evaluate the safety and clinical effectiveness of the VDyne System for the treatment of symptomatic severe or greater tricuspid regurgitation.
View original scientific description
Pivotal trial to evaluate the safety and clinical efficacy of the VDyne System for the treatment of symptomatic severe or greater tricuspid regurgitation.
Interventions
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).
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).
Primary outcome measures
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
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.
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether 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
Where
- Minneapolis, Minnesota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 17, 2026 · Source of record for eligibility and locations