Clinical Research Directory

The following inclusion criteria were defined to assure generalizability of the population to be studied: * Subject is symptomatic due to severe TR despite being on stable OMT for at least 30 days based on judgment of the local heart team. * Subject is at intermediate or greater estimated risk of morbidity and mortality, defined as a) hospitalization for heart failure during the previous 12 months, or b) cardio-renal syndromea or c) cardio-hepatic syndrome * New York Heart Association (NYHA) Functional Class II, III or IVa * Femoral vein access and valve anatomy are determined to be feasible for interventional treatment (including sufficient quality of TTE and TEE imaging) * Age ≥ 18 years at time of consent * Subject must provide written informed consent prior to any trial related procedure The following exclusion criteria were selected to define a representative study cohort: * Presence of severe aortic, mitral or pulmonary valve disease OR surgical/interventional treatment at the aortic, mitral or pulmonary valves prior 60 days * Right heart catheterization (mandatory) with systolic pulmonary artery pressure \> 70 mmHg or substantial pre-capillary pulmonary hypertension (defined as mean pulmonary artery pressure (mPAP) \>30 mmHg plus transpulmonary gradient (TPG) \>17 mmHg or pulmonary vascular resistance (PVR) \>5 wood units) * Tricuspid valve stenosis (tricuspid mean gradient \> 5 mmHg) * Pacemaker or ICD leads that would prevent appropriate TTVT * Prior tricuspid valve procedures or tricuspid valve leaflet anatomy that would interfere with appropriate TTVT (e.g. calcification, Ebstein anomaly, coaptation defect \> 8mm for planned leaflet- and annuloplasty-based therapy) * Chronic renal failure requiring dialysis * Tricuspid valve anatomy not evaluable by TTE and TEE * Myocardial infarction or cerebrovascular accident within prior 90 days * Life expectancy of less than 12 months