TTVR Early Feasibility Study

Inclusion Criteria: * Heart Team agrees that patient is deemed symptomatic despite medical therapy (including obligatory diuretic) and a candidate for bioprosthetic tricuspid valve replacement * Subject is at an intermediate or greater estimated risk of mortality with tricuspid valve surgery as determined by the local Heart Team * Subjects with severe symptomatic primary and / or secondary tricuspid regurgitation determined by the Echocardiography Core Lab assessment of a qualifying transthoracic echocardiogram (TTE) and transesophageal echocardiogram (TEE) * New York Heart Association (NYHA) Function Class II or greater * Subject anatomically suitable for the Intrepid TTVR delivery system including transfemoral access * Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits * Subject meets the legal minimum age to provide informed consent based on local regulatory requirements Exclusion Criteria: * Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions * Anatomic contraindications for Intrepid™ TTVR (e.g., annular dimensions) * Evidence of intracardiac mass, inferior vena cava, or femoral venous mass or thrombus * Implanted with venous stents (iliac and/or femoral) or inferior vena cava (IVC) filter or congenital abnormalities of the IVC that would preclude ability for transfemoral access of delivery system * Echocardiographic evidence of severe right ventricular dysfunction * Left ventricular ejection fraction (LVEF) \<30 as measured by resting echocardiogram within 30 days of the Index Procedure * Need for emergent or urgent surgery * Untreated clinically significant coronary artery disease requiring revascularization * Carcinoid tricuspid regurgitation

Reproduced word-for-word from the public registry record — the study team can answer questions about it.