Treatment of Severe Secondary TRIcuspid Regurgitation in Patients With Advance Heart Failure With CAval Vein Implantation of the Edwards Sapien XT VALve (TRICAVAL)

Inclusion Criteria: * Severe symptomatic tricuspid regurgitation with a significant regurgitation jet into the caval and hepatic veins * Optimal medical treatment * High surgical risk with STS Score ≥ 10 or logistic EuroSCORE I ≥ 15 or any contraindication for conventional valve replacement/repair * NYHA class of at least II * Written informed consent Exclusion Criteria: * VCI diameter \> 32 mm * Severe left ventricular dysfunction with LVEF \< 30% * Severe mitral insufficiency * Estimated life expectancy \< 12months (360 days) due to carcinoma, chronic liver disease, chronic renal disease or chronic end stage pulmonary disease * Evidence of an acute myocardial infarction ≤ 1 month before the intended treatment * Evidence of stroke / TIA during the last 180 days * Leukopenia (WBC \< 3000 cell/mL), anemia (Hgb \< 9 g/dL), Thrombocytopenia (Plt \< 50,000 cells/mL), or any known blood clotting disorder * Evidence of an intracardiac mass, thrombus or vegetation * Active upper GI bleeding within 1 month (30 days) prior to procedure * Patients with an acute emergency * Contraindication or hypersensitivity to all anticoagulation regimens, or inability to be anticoagulated for the study procedure * Allergy against the use of implanted stent / prosthesis * Patient undergoing regular dialysis or a serum creatinine above 3.0 mg/dl * Patients unsuitable for implantation because of thrombosis of the lower venous system or vena cava filter * Active bacterial endocarditis within 6 months…