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

ConditionsTricuspid Valve RegurgitationTricuspid Valve DiseaseCardiovascular Diseases (CVD)Heart Valve DiseasesTricuspid Valve InsufficiencySevere Heart Valve DiseaseRandomized Controlled Trial (RCT)Symptomatic Tricuspid Regurgitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVDyne, Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

  • 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).

Treatment groups

730 Participants
are divided into 3 treatment groups
Group A: Randomized cohort VDyne TTVRExperimental treatment 1 intervention
Group B: Randomized cohort Edwards EVOQUE TTVRActive comparator 1 intervention
Group C: Single Arm RegistryExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
30 days post-procedure
2

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.

Time frame
12 months post-procedure
3

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.

Time frame
12 months post procedure
4

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.

Time frame
12 months post procedure

Secondary outcomes

1

All-Cause Mortality

Total number of deaths from any cause

Time frame
At 12 months and 24 months
2

RVAD implantation or heart transplant

Total number of patients requiring Right Ventricular Assist Device (RVAD) implantation or heart transplant

Time frame
At 12 months and 24 months
3

Tricuspid valve surgical or percutaneous intervention

Total number of non-elective tricuspid valve re-interventions

Time frame
At 12 months and 24 months
4

Heart failure hospitalizations

Total number of patients with at least one hospital admission due to heart failure

Time frame
At 12 months and 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VDyne, Inc.

Lead sponsor

Source ClinicalTrials.gov
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