TRICAV-I

Conditions studied

Tricuspid Regurgitation, Tricuspid Valve Disease

What is being tested

• DEVICE: TricValve® Transcatheter Bicaval Valve System

What it measures

• Emergency surgery or intervention related to the device/procedure complications, Number of days until emergency surgery or intervention, 1 Month
• Heart Failure Events, Number of heart failure episodes including hospitalization, or worsening heart failure, 12 Months
• Kansas City Cardiomyopathy Questionnaire (KCCQ) Score, Change in KCC score (score ranges between 0 and 100), 12 Months
• Major vascular, access-related, or cardiac structural complication, Number of days until death, 1 Month
• Mortality, Number of days until death, 1 Month and 12 Months
• New York Heart Association (NYHA class), Change in NYHA class (range from I to IV), 12 Months
• Pulmonary Embolism, Number of days until death, 1 Month
• Right Ventricular Assist Device (RVAD) implantation or heart transplant, Number of days until Right Ventricular Assist Device (RVAD) implantation or heart transplant, 12 Months
• Six Minute Walking Test (6MWT), Change in walking distance, 12 Months
• Stage 3 Acute Kidney Injury with increase in serum creatinine >300% (>3.0x increase) and/or serum creatinine ≥4.0mg/dL (≥354 μmol/L) with an acute increase of ≥ 0.5 mg/dL (≥44 μmol/L), Number of days from baseline until increase, 7 Days
• Stage 4 Acute Kidney Injury requiring new temporary or permanent renal replacement therapy, Number of days until new renal replacement therapy, 1 Month
• Stroke, Number of days until death, 1 Month
• Tricuspid valve surgery or percutaneous tricuspid intervention, Number of days until tricuspid valve surgery or percutaneous tricuspid intervention, 12 Months
• Valve Academic Research Consortium (VARC) type 2-4 bleeding complication, Number of days until death, 1 Month

Working with

Meditrial USA Inc., P+F Products + Features GmbH