TTVR Early Feasibility Study
Study Phase: N/A
Recruitment Status: Recruiting
Start Date: October 20, 2020
End Date: July 30, 2031
Julia Katilius
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
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Conditions:
- Tricuspid Valve Insufficiency