TTVR Early Feasibility Study

The Early Feasibility Study of the Transcatheter Tricuspid Valve Replacement System Transfemoral System

The objective of this early feasibility study is to gain early clinical insight into the performance of the Intrepid transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve.

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