Study of Transcatheter Tricuspid Annular Repair
The purpose of the study is to evaluate the safety and performance of the MIA Minimally Invasive Annuloplasty Device in patients with chronic functional tricuspid regurgitation.
• Chronic functional tricuspid regurgitation (FTR) with a minimum of moderate tricuspid regurgitation (2-4)
• Age≥18 and ≤85 years old
• New York Heart Association (NYHA) Class II, III or ambulatory IV
• Left ventricular ejection fraction (LVEF) ≥30%
• Undergoing cardiac surgical procedure with the planned use of cardiopulmonary bypass (surgical arm only)
• Functional tricuspid valve regurgitation pathology with a structurally normal valve; and tricuspid valve annular diameter ≥ 40 mm (or 21 mm/m2) and ≤55 mm (or 29 mm/m2) or 2-4 + FTR
• Patient provides written Informed Consent before any study-specific tests or procedures are performed
• Patient is willing and able to comply with all specified study evaluations