Evaluate Cardiovascular Outcomes in Patients Treated with the Tricuspid Valve Repair System Pivotal (Triluminate)

The primary objective of this trial is to demonstrate the safety and effectiveness of the TriClip™ device in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR), who are at intermediate or greater estimated risk for mortality of morbidity with tricuspid valve surgery. This randomized controlled trial will compare the investigational device (TriClip device™) to Control (Medical Therapy).

Inova Fairfax Hospital
3300 Gallows Rd.
Falls Church, VA 22042

• Subjects who are at least 18 years of age at the time of informed consent
• NYHA functional class II,III or ambulatory class IV
• Medical and/or device therapy for mitral regurgitation, atrial fibrillation, coronary artery disease and heart failure
• Subject is symptomatic with severe TR despite being optimally treated as described above
• TR severity is determined by the assessment of a qualifying TTE and confirmed by the ECHO Core

• Any prior tricuspid valve procedure that would interfere with placement of the TriClip™ device
• Left Ventricular Ejection Fraction (LVEF) <20%
• Severe uncontrolled hypertension Systolic Blood Pressure >180 and/or diastolic >110
• Systolic pulmonary artery pressure >70mmHg or fixed pre-capillary pulmonary hypertension as assessed by right heart catheterization
• Indication for left-sided (e.g. severe aortic stenosis, severe mitral regurgitation) or pulmonary valve correction prior 60 days
• Tricuspid valve stenosis
• Chronic dialysis
• Tricuspid valve anatomy not evaluable by TTE and TEE
• Pacemaker or ICD leads that would prevent appropriate placement of the TriCLip™ device
• Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease
• Tricuspid valve leaflet anatomy which may preclude clip implantation, proper clip positioning on the leaflets
• Bleeding disorders or hypercoagulable state
• Active peptic ulcer or GI bleed
• Contraindication, allergy or hypersensitivity to dual antiplatelet and anticoagulation therapy
• Ongoing infection requiring current antibiotic therapy
• Evidence of intracardiac, inferior vena cava or femoral venous mass, thrombus or vegetation
• Cerebrovascular Accident (CVA) within 90 days
• MI or known unstable angina with prior 30 days or percutaneous coronary intervention within 30 days