TRIVITA

Conditions studied

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

What is being tested

• DEVICE: Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE System
• DEVICE: Transcatheter Tricuspid Valve Replacement (TTVR) with VDyne System

What it measures

• 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
• 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
• 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