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 valvereplacement

• Subject is at an intermediate or greater estimated risk of mortality with tricuspidvalve surgery as determined by the local Heart Team

• Subjects with severe symptomatic primary and / or secondary tricuspid regurgitationdetermined by the Echocardiography Core Lab assessment of a qualifying transthoracicechocardiogram (TTE) and transesophageal echocardiogram (TEE)

• New York Heart Association (NYHA) Function Class II or greater

• Subject anatomically suitable for the Intrepid TTVR delivery system includingtransfemoral access

• Subject and the treating physician agree that the subject will return for allrequired post-procedure follow-up visits

• Subject meets the legal minimum age to provide informed consent based on localregulatory requirements

Exclusion Criteria:

• Estimated life expectancy of less than 24 months due to associated non-cardiacco-morbid conditions

• Anatomic contraindications for Intrepid™ TTVR (e.g., annular dimensions)

• Evidence of intracardiac mass, inferior vena cava, or femoral venous mass orthrombus

• Implanted with venous stents (iliac and/or femoral) or inferior vena cava (IVC)filter or congenital abnormalities of the IVC that would preclude ability fortransfemoral access of delivery system

• Echocardiographic evidence of severe right ventricular dysfunction

• Left ventricular ejection fraction (LVEF) <30 as measured by resting echocardiogramwithin 30 days of the Index Procedure

• Need for emergent or urgent surgery

• Untreated clinically significant coronary artery disease requiring revascularization

• Carcinoid tricuspid regurgitation