Research Study: TRICAV ll
Every research study comes with its own unique risks and benefits; the study team will assess whether you’re an eligible candidate and ensure you’re provided with all the information you need to decide if participating is right for you.
About this Study:
The Investigational Device is the TricValve Transcatheter Bicaval Valve System (also referred to as the TricValve System).
The bioprosthesis is available in two different diameters for each model (SVC and IVC) specifically designed to adapt to the anatomic features of the superior vena cava (SVC) and inferior vena cava (IVC).
The SVC and IVC valves are single use, sterile devices provided in two sizes each, for a total of four valve sizes. The valves are designed for heterotopic caval implantation without perturbing the native tricuspid valve. The valves are made of bovine pericardium leaflets sutured on a nitinol self-expanding stent system.
The SVC and IVC valves are provided pre-mounted in two separate TricValve Delivery Systems, and are individually packaged into two separate boxes, provided sterile and ready to use. The two TricValve Delivery Systems deliver the two valves percutaneously into the SVC and IVC via femoral vein access using a transvenous approach.
Eligibility Criteria:
Inclusion Criteria:
- Patient with severe aortic regurgitation (AR).
- Patient at high risk for open surgical valve replacement
- Patient symptomatic according to NYHA functional class II or higher
- The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB)/ Ethics Committee (EC) of the respective clinical site.
Exclusion Criteria:
- Congenital uni or bicuspid aortic valve morphology
- Previous prosthetic aortic valve (bioprosthesis or mechanical) implant
- Endocarditis or other active infection
- Need for urgent or emergent TAVR procedure for any reason
- Cardiogenic shock or hemodynamic instability requiring inotropic support or ventricular assist device
- Severe mitral regurgitation
