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

NCT07516444 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: CIP-CL-001
• Study Type: interventional
• Target: 730
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Tricuspid Valve Regurgitation; Tricuspid Valve Disease; Heart Valve Diseases; Tricuspid Valve Insufficiency; Randomized Controlled Trial (RCT); Cardiovascular Diseases (CVD); Severe Heart Valve Disease; Symptomatic Tricuspid Regurgitation

Keywords

VDyne; TRIVITA; TRIVITA Pivotal; Tricuspid Regurgitation

Outcome Measures

Primary Outcomes (4)

• 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

  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.

  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.

  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.

  12 months post procedure

Secondary Outcomes (8)

• All-Cause Mortality

  At 12 months and 24 months

• RVAD implantation or heart transplant

  At 12 months and 24 months

• Tricuspid valve surgical or percutaneous intervention

  At 12 months and 24 months

• Heart failure hospitalizations

  At 12 months and 24 months

• Change in Quality of Life (QOL) as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)

  At 12 months and 24 months

Study Arms (3)

Randomized cohort VDyne TTVR

EXPERIMENTAL

Transcatheter tricuspid valve replacement with VDyne System in patients with severe or greater tricuspid regurgitation.

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.

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.

Device: Transcatheter Tricuspid Valve Replacement (TTVR) with VDyne System

Interventions

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).

Also known as: Transcatheter Tricuspid Valve Replacement

Randomized cohort Edwards EVOQUE TTVR

Transcatheter Tricuspid Valve Replacement (TTVR) with VDyne System DEVICE

Subjects will undergo TTVR procedure with VDyne device and will continue to be managed on Optimal Medical Therapy (OMT).

Also known as: Transcatheter Tricuspid Valve Replacement

Randomized cohort VDyne TTVR; Single Arm Registry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VDyne, Inc.: lead

Related Publications (4)

• 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.

  PMID: 40551865 BACKGROUND

• Fam 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.

  PMID: 33582084 BACKGROUND

• Hahn 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.

  PMID: 39475399 BACKGROUND

• Arnold 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.

  PMID: 39480380 BACKGROUND

MeSH Terms

Conditions

Tricuspid Valve Insufficiency; Cardiovascular Diseases; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart 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: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: April 8, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2036
• Last Updated: April 8, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share