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

General Information Age Group Adults Status Active Protocol Number NCT03904147 Background Information 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). Offered At Inova Fairfax Hospital 3300 Gallows Rd. Falls Church, VA 22042 Principal Investigator Wayne Batchelor, MD Eligibility Information 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 Ineligibility Information 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 Contact Information Contact Name Tracy Plummer Contact Phone 703-776-3567 Contact Email Send Email