TRICAV-II

Conditions studied

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

What is being tested

• DEVICE: TricValve System
• DRUG: Optimal medical therapy

What it measures

• Randomized Cohort: Caval Reflux (CR) grade reduction, Reduction in Caval Reflux (CR) assessed by the echocardiography core laboratory. The CR will be assessed using the 3-grade scale: Grade 1 (no reflux, reflux extending for less than 1 cm below the diaphragm), Grade 2 ( reflux extending for less than 3 cm), Grade 3 (reflux of 3 cm or more). Lower grades of CR 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 clinical outcomes using a single hierarchical analysis. Treatment effect will be summarized using Win Ratio statistics, where a value greater than 1 indicates improved outcomes in the experimental group compared with the comparator arm., 6 months
• Randomized Cohort: Hierarchical composite endpoint: all-cause mortality, RVAD implantation or heart transplant, tricuspid valve surgery or percutaneous tricuspid intervention, heart failure hospitalizations, KCCQ improvement, NYHA functional class improv, Comparison of clinical outcomes using a single hierarchical analysis. Treatment effect will be summarized using Win Ratio statistics, where a value greater than 1 indicates improved outcomes in the experimental group compared with the comparator arm., 1 year
• Randomized Cohort: Rate of Major Adverse Events (MAE), Rate of Major Adverse Events (MAE) in experimental arm (TricValve + OMT), 30 days
• Registry Cohort: Rate of Major Adverse Events (MAE), Rate of Major Adverse Events (MAE) in single arm registry, 30 days

Working with

Meditrial USA Inc.