TRISCEND II Pivotal Trial

Conditions studied

Cardiovascular Diseases, Heart Failure, Heart Valve Diseases, Tricuspid Valve Disease, Tricuspid Valve Insufficiency, Tricuspid Valve Regurgitation

What is being tested

• DEVICE: Edwards EVOQUE System
• DRUG: Optimal Medical Therapy

What it measures

• Continued Access Study: 6MWD, 6MWD improvement of at least 30 meters, 1 year
• Continued Access Study: 6MWD, 6MWD improvement of at least 30 meters, 6 months
• Continued Access Study: All-cause mortality, Deaths from any cause, 1 year
• Continued Access Study: Annualized rate of heart failure hospitalizations, Annualized rate of heart failure hospitalizations, 1 year
• Continued Access Study: Durable right ventricular assist device (RVAD) implantation or heart transplant, Durable RVAD implantation or heart transplant, 1 year
• Continued Access Study: New York Heart Association (NYHA) functional class, NYHA functional class improvement of at least 1 class. NYHA functional classification system categorizes heart failure patients into 4 classes based on physical activity limitation and symptom severity: class I (no symptoms and no limitation in ordinary physical activity), class II (mild symptoms and slight limitation during ordinary activity), class III (marked limitation in activity due to symptoms, even during less-than-ordinary activity; comfortable only at rest, and class IV (severe limitations; experiences symptoms even while at rest)., 1 year
• Continued Access Study: New York Heart Association (NYHA) functional class, NYHA functional class improvement of at least 1 class. NYHA functional classification system categorizes heart failure patients into 4 classes based on physical activity limitation and symptom severity: class I (no symptoms and no limitation in ordinary physical activity), class II (mild symptoms and slight limitation during ordinary activity), class III (marked limitation in activity due to symptoms, even during less-than-ordinary activity; comfortable only at rest, and class IV (severe limitations; experiences symptoms even while at rest)., 6 months
• Continued Access Study: Quality of Life (QOL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ), Improvement in QOL (by KCCQ overall summary score) of at least 10 points. KCCQ overall summary score is a patient-reported measure of health status, ranging from 0 to 100, where higher scores reflect better QOL., 1 year
• Continued Access Study: Quality of Life (QOL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ), Improvement in QOL (by KCCQ overall summary score) of at least 10 points. KCCQ overall summary score is a patient-reported measure of health status, ranging from 0 to 100, where higher scores reflect better QOL., 6 months
• Continued Access Study: Rate of Major Adverse Events (MAE), Rate of MAEs in the Continued Access Study arm, 30 days
• Continued Access Study: Total number of patients requiring tricuspid valve surgery or percutaneous tricuspid intervention, Total number of patients requiring tricuspid valve surgery or percutaneous tricuspid intervention., 1 year
• Continued Access Study: Tricuspid Regurgitation (TR) grade reduction to moderate, mild, or none/trace, TR grade reduction to moderate, mild, or none/trace from baseline. TR severity will be assessed using the 5-grade scale with the addition of "none/trace" to represent the lack of TR (scale: none/trace, mild, moderate, severe, massive, torrential); Lower grades of TR are better., 6 months
• Randomized Cohort: Hierarchical composite endpoint including: Kansas City Cardiomyopathy Questionnaire (KCCQ) improvement, New York Heart Association (NYHA) functional class improvement, and 6-minute walk test distance improvement, Comparison of number of wins with composite endpoint event improvement between experimental and active comparator arms, 6 months
• Randomized Cohort: Hierarchical composite endpoint: all-cause mortality, RVAD implantation or heart transplant, tricuspid valve intervention, heart failure hospitalizations, KCCQ improvement, NYHA functional class improvement, and 6MWD improvement, Comparison of number of wins with composite endpoint events or improvement between experimental and active comparator arms, 1 year
• Randomized Cohort: Rate of Major Adverse Events (MAE), Rate of Major Adverse Events (MAE) in experimental arm (Edwards EVOQUE System \& OMT), 30 days
• Randomized Cohort: Tricuspid Regurgitation (TR) grade reduction, Comparison of number of participants with reduction in TR between experimental and active comparator arms. TR severity will be assessed using the 5-grade scale with the addition of "none/trace" to represent the lack of TR (scale: none/trace, mild, moderate, severe, massive, torrential). Lower grades of TR are better., 6 months