Cardiovascular Diseases (CVD), Heart Valve Diseases, Randomized Controlled Trial (RCT), Severe Heart Valve Disease, Symptomatic Tricuspid Regurgitation, Tricuspid Valve Disease, Tricuspid Valve Insufficiency, Tricuspid Valve Regurgitation
Conditions
Keywords
VDyne, TRIVITA, TRIVITA Pivotal, Tricuspid Regurgitation
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.
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
DEVICETranscatheter 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).
DEVICETranscatheter 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).
Sponsors
VDyne, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of all-cause mortality, heart failure hospitalization, or non-elective tricuspid valve reintervention | 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) | 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) | 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. |
| Composite of major adverse events (MAEs) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life (QOL) as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) | At 12 months and 24 months | 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) | 12 months | 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. |
| Change in 6-Minute Walk Distance (6MWD) | At 12 months and 24 months | 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. |
| Heart failure hospitalizations | At 12 months and 24 months | Total number of patients with at least one hospital admission due to heart failure |
| Change in Echocardiographic Tricuspid Regurgitation (TR) grade from baseline using TransThoracic Echocardiogram (TTE) | At 6 months, 12 months and 24 months post-implant compared to baseline | 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. |
| RVAD implantation or heart transplant | At 12 months and 24 months | Total number of patients requiring Right Ventricular Assist Device (RVAD) implantation or heart transplant |
| Tricuspid valve surgical or percutaneous intervention | At 12 months and 24 months | Total number of non-elective tricuspid valve re-interventions |
| All-Cause Mortality | At 12 months and 24 months | Total number of deaths from any cause |
Countries
United States
Contacts
CONTACTVinny Podichetty
CONTACTJeya Satheesh
Outcome results
None listed