Clinical Research Directory

General Inclusion Criteria * Male or female age ≥18 yrs * Carcinoid Heart Disease * NYHA Class II - IV * Severe symptomatic tricuspid regurgitation * Inoperable due to active tumour process or patient declines an operative intervention * Patient willing and able to consent and comply with specified study evaluations * Adequate understanding of written or spoken English (to complete validated questionnaires) General Exclusion Criteria * Previous tricuspid valve repair or replacement * Permanent vena cava filter * Mega atrium * Tricuspid valve stenosis * Thrombosis of lower venous system * Severe uncontrolled hypertension (Systolic BP ≥ 180 mmHg and/or Diastolic BP ≥ 110 mm Hg) * Active endocarditis * Subject is on chronic dialysis * Bleeding disorders or hypercoaguable state * Hemodynamic instability or on IV inotropes * Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically eg contrast * Contraindication to anticoagulants or antiplatelet medication * Known allergy to Nitinol (Titanium or Nickel) alloy, gold or porcine tissue * Untreated clinically significant coronary artery disease requiring revascularization * Any Percutaneous Coronary Intervention (PCI) or transcatheter valvular intervention within 30 days prior to the index procedure or planned 3 months post the index procedure * Myocardial Infarction (MI) or known unstable angina within the 30 days prior to the index procedure * Pregnant or lactating; or female of childbearing potential with a positive pregnancy test 24 hours before any study-related radiation exposure * Contraindication to long-term anticoagulation * Life expectancy according to tumour development is less than 12 months * Impaired judgment and/or is undergoing emergency treatment