TRISCEND II Pivotal Trial
Condition: Tricuspid regurgitation
Key Inclusion Criteria
- At least 18 years old
- Despite medical therapy, patient has signs of tricuspid regurgitation (TR), symptoms from TR, or prior heart failure hospitalization from TR
- Functional and/or degenerative TR graded as at least severe on a transthoracic echocardiogram
Key Exclusion Criteria
- Tricuspid valve anatomy precluding proper device deployment and function
- Specific echocardiographic parameters (such as LVEF < 25% or evidence of severe right ventricular dysfunction)
- Previous tricuspid surgery or intervention that could interfere with placement of the EVOQUE System
Full Study Name
Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy Using a Novel Device (IRB no. 0000967)
This study focuses on adults who have tricuspid regurgitation (TR), a condition in which the heart’s tricuspid valve does not close tightly, causing blood to flow backwards in the wrong direction. The purpose of the study is to evaluate the safety and effectiveness of an investigational device called the EVOQUE system with Optimal Medical Therapy (OMT) compared to OMT alone in the treatment of patients with severe or greater tricuspid regurgitation.
The EVOQUE Valve is an artificial valve made from bovine pericardial (cow heart) tissue, nitinol (metal) frame, and a fabric skirt. The valve is designed to replace the tricuspid heart valve without open-heart surgery and is implanted using a delivery catheter.