TTVR Early Feasibility Study

Multi-center, prospective, non-randomized, investigational, and pre-market.

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