Tricuspid Valve RegurgitationTRIVITANCT07516444
VDyne Transcatheter Tricuspid Valve Replacement Study to Evaluate Safety and Clinical Efficacy in Patients With Symptomatic Severe Tricuspid Valve Regurgitation (TRIVITA Pivotal Trial)
A study testing Transcatheter Tricuspid Valve Replacement (TTVR) with VDyne System and Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE System in people with Tricuspid Valve Regurgitation and Tricuspid Valve Disease, run by VDyne, Inc. at 1 site in United States.
Trial summary
Pivotal trial to evaluate the safety and clinical efficacy of the VDyne System for the treatment of symptomatic severe or greater tricuspid regurgitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Valve Regurgitation, Tricuspid Valve Disease, Cardiovascular Diseases (CVD)
- What is being tested?
- Transcatheter Tricuspid Valve Replacement (TTVR) with VDyne System and Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 730 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2026to Jun 2036
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Nikki Clinical Research Manager, 6128636286, nikki.degeneffe@allina.com
Konstantinos Voudris
About this study
Official title: 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.
Read the 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.
- Conditions
- Tricuspid Valve Regurgitation, Tricuspid Valve Disease, Cardiovascular Diseases (CVD), Heart Valve Diseases, Tricuspid Valve Insufficiency, Severe Heart Valve Disease
- Being tested
- Transcatheter Tricuspid Valve Replacement (TTVR) with VDyne System, Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE System
- Keywords
- VDyne, TRIVITA, TRIVITA Pivotal, Tricuspid Regurgitation
- Medical subject headings
- Tricuspid Valve Insufficiency, Cardiovascular Diseases, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Tricuspid Valve Replacement (TTVR) with VDyne SystemDevice
Also called Transcatheter Tricuspid Valve Replacement
Subjects will undergo TTVR procedure with VDyne device and will continue to be managed on Optimal Medical Therapy (OMT).
Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE SystemDevice
Also called Transcatheter Tricuspid Valve Replacement
Subjects will undergo TTVR procedure with Edwards EVOQUE device and will continue to be managed on Optimal Medical Therapy (OMT).
| Study group | Role | What they receive |
|---|---|---|
| Randomized cohort VDyne TTVR | Experimental | Transcatheter tricuspid valve replacement with VDyne System in patients with severe or greater tricuspid regurgitation. Receives: Device: Transcatheter Tricuspid Valve Replacement (TTVR) with VDyne System |
| Randomized cohort Edwards EVOQUE TTVR | Active comparator | Transcatheter tricuspid valve replacement with Edwards EVOQUE System in patients with severe or greater tricuspid regurgitation. Receives: Device: Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE System |
| Single Arm Registry | Experimental | 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. Receives: Device: Transcatheter Tricuspid Valve Replacement (TTVR) with VDyne System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of major adverse events (MAEs)
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
Measured: 30 days post-procedure
Composite of all-cause mortality, heart failure hospitalization, or non-elective tricuspid valve reintervention
All-cause mortality, heart failure hospitalization and non-elective tricuspid valve reintervention will be adjudicated by a Clinical Events Committee.
Measured: 12 months post-procedure
Change in Quality of Life (QOL) as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)
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.
Measured: 12 months post procedure
Change in Quality of Life (QOL) as measured by New York Heart Association (NYHA)
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.
Measured: 12 months post procedure
Secondary outcomes (8)
All-Cause Mortality
Total number of deaths from any cause
Measured: At 12 months and 24 months
RVAD implantation or heart transplant
Total number of patients requiring Right Ventricular Assist Device (RVAD) implantation or heart transplant
Measured: At 12 months and 24 months
Tricuspid valve surgical or percutaneous intervention
Total number of non-elective tricuspid valve re-interventions
Measured: At 12 months and 24 months
Heart failure hospitalizations
Total number of patients with at least one hospital admission due to heart failure
Measured: At 12 months and 24 months
Change in Quality of Life (QOL) as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)
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.
Measured: At 12 months and 24 months
Change in Quality of Life (QOL) as measured by New York Heart Association (NYHA)
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.
Measured: 12 months
Change in 6-Minute Walk Distance (6MWD)
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.
Measured: At 12 months and 24 months
Change in Echocardiographic Tricuspid Regurgitation (TR) grade from baseline using TransThoracic Echocardiogram (TTE)
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.
Measured: At 6 months, 12 months and 24 months post-implant compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start28 Jul 2026
- Primary completionJun 2029 (estimated)
- Study completionJun 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Tricuspid Valve RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 730 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VDyne, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516444
- Sponsor's protocol ID
- CIP-CL-001
- Acronym
- TRIVITA
- Status last verified
- Aug 2026
- First submitted
- 25 Mar 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Azami P, Hosseinpour A, Kamalpour J, Rajabi F, Razeghian-Jahromi I, Farhangdoost S, Vafa RG, Bagheri G. Efficacy and Safety of Transcatheter Tricuspid Valve Replacement in Patients With Moderate to Severe Tricuspid Regurgitation: A Systematic Review and Meta-Analysis on Clinical Outcomes and Echocardiographic Indices. Health Sci Rep. 2025 Jun 23;8(6):e70950. doi: 10.1002/hsr2.70950. eCollection 2025 Jun.
PubMed 40551865Fam NP, von Bardeleben RS, Hensey M, Kodali SK, Smith RL, Hausleiter J, Ong G, Boone R, Ruf T, George I, Szerlip M, Nabauer M, Ali FM, Moss R, Bapat V, Schnitzler K, Kreidel F, Ye J, Deva DP, Mack MJ, Grayburn PA, Peterson MD, Leon MB, Hahn RT, Webb JG. Transfemoral Transcatheter Tricuspid Valve Replacement With the EVOQUE System: A Multicenter, Observational, First-in-Human Experience. JACC Cardiovasc Interv. 2021 Mar 8;14(5):501-511. doi: 10.1016/j.jcin.2020.11.045. Epub 2021 Feb 10.
PubMed 33582084Hahn RT, Makkar R, Thourani VH, Makar M, Sharma RP, Haeffele C, Davidson CJ, Narang A, O'Neill B, Lee J, Yadav P, Zahr F, Chadderdon S, Eleid M, Pislaru S, Smith R, Szerlip M, Whisenant B, Sekaran NK, Garcia S, Stewart-Dehner T, Thiele H, Kipperman R, Koulogiannis K, Lim DS, Fowler D, Kapadia S, Harb SC, Grayburn PA, Sannino A, Mack MJ, Leon MB, Lurz P, Kodali SK; TRISCEND II Trial Investigators. Transcatheter Valve Replacement in Severe Tricuspid Regurgitation. N Engl J Med. 2025 Jan 9;392(2):115-126. doi: 10.1056/NEJMoa2401918. Epub 2024 Oct 30.
PubMed 39475399Arnold SV, Hahn RT, Thourani VH, Makkar R, Makar M, Sharma RP, Haeffele C, Davidson CJ, Narang A, O'Neill B, Lee J, Yadav P, Zahr F, Chadderdon S, Eleid M, Pislaru S, Smith R, Szerlip M, Whisenant B, Sekaran N, Garcia S, Stewart-Dehner T, Grayburn PA, Sannino A, Snyder C, Zhang Y, Mack MJ, Leon MB, Lurz P, Kodali S, Cohen DJ; TRISCEND II Pivotal Trial Investigators. Quality of Life After Transcatheter Tricuspid Valve Replacement: 1-Year Results From TRISCEND II Pivotal Trial. J Am Coll Cardiol. 2025 Jan 28;85(3):206-216. doi: 10.1016/j.jacc.2024.10.067. Epub 2024 Oct 30.
PubMed 39480380