Pivotal trial to evaluate the safety and clinical efficacy of the VDyne System for the treatment of symptomatic severe or greater tricuspid regurgitation.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
730
Subjects will undergo TTVR procedure with VDyne device and will continue to be managed on Optimal Medical Therapy (OMT).
Subjects will undergo TTVR procedure with Edwards EVOQUE device and will continue to be managed on Optimal Medical Therapy (OMT).
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
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
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
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
All-Cause Mortality
Total number of deaths from any cause
Time frame: 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
Time frame: At 12 months and 24 months
Tricuspid valve surgical or percutaneous intervention
Total number of non-elective tricuspid valve re-interventions
Time frame: At 12 months and 24 months
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
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: 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.
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Time frame: 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.
Time frame: At 12 months and 24 months
Change in Echocardiographic Tricuspid Regurgitation (TR) grade from baseline using TransEsophageal Echocardiogram (TEE)
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 TransEsophageal Echocardiogram (TEE) imaging.
Time frame: At 6 months, 12 months and 24 months post-implant compared to baseline