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

Official title

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

Overview

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

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.

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 all-cause mortality, heart failure hospitalization, or non-elective tricuspid valve reintervention [Time frame: 12 months post-procedure]
• Change in Quality of Life (QOL) as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) [Time frame: 12 months post procedure]
• Change in Quality of Life (QOL) as measured by New York Heart Association (NYHA) [Time frame: 12 months post procedure]

Secondary outcome measures (8)

• All-Cause Mortality [Time frame: At 12 months and 24 months]
• RVAD implantation or heart transplant [Time frame: At 12 months and 24 months]
• Tricuspid valve surgical or percutaneous intervention [Time frame: At 12 months and 24 months]
• Heart failure hospitalizations [Time frame: 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]
• Change in Quality of Life (QOL) as measured by New York Heart Association (NYHA) [Time frame: 12 months]
• Change in 6-Minute Walk Distance (6MWD) [Time frame: 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

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 20 PMID 40551865
• 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 Cardi PMID 33582084
• 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. PMID 39475399
• 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 Transcath PMID 39480380

Identifiers

NCT: NCT07516444 · CIP-CL-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗