Active, not recruitingNCT03851068
Early Feasibility Study for the Foldax Tria Aortic Heart Valve
AI Description
The purpose of this study is to conduct the initial clinical investigation of the Foldax Polymer Aortic Valve to collect evidence on the device's safety and performance. The study is anticipated to confirm successful clinical safety and clinical effectiveness with significant improvements in clinical hemodynamic performance.
- Who can join
- adult, older adult
- Participants
- 40
- Expected completion
- 2026-12
- Funded by
- industry
Conditions studied
Aortic Valve Disease, Aortic Valve Stenosis
What is being tested
- DEVICE: Foldax Tria Aortic Valve
What it measures
- Primary Effectiveness Endpoint: Hemodynamic Performance Assessment, Hemodynamic performance parameters are mmHG mean gradient and derived Effective Orifice Area (EOA). Success is defined as clinically significant improvement in hemodynamic performance (Effective Orifice Area (EOA)) at one year based on literature reports for surgical aortic valve replacement., 12 months following patient enrollment completion
- Primary Effectiveness Endpoint: New York Heart Association Improvement Assessment, Clinically significant improvement (one grade) in the New York Heart Association (NYHA) functional classification status at 365 days compared to baseline. a. Class I - No symptoms and no limitations in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. b. Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. c. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100m). Comfortable only at rest. d. Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients., 12 months following patient enrollment completion
- Primary Safety Endpoints: Objective Performance Criteria for Flexible Heart Valve Events Assessments, The adverse events consistent with the Objective Performance Criteria (OPC), for flexible heart valves will be compared to those rates defined as acceptable levels in the standard. a. Thromboembolism b. Valve Thrombosis c. Major Paravalvular leak d. Major Hemorrhage e. Endocarditis, 12 months following patient enrollment completion
- Primary Safety Endpoints: Surgical Valve Events Rate Assessment, The rates of other events will be compared to clinical outcomes for surgically implanted heart valves reported in the literature. a. All-caused death b. Valve related death c. Valve-related reoperation d. Valve explant e. Hemorrhage f. All-cause reoperation g. Valve-related death, 12 months following patient enrollment completion
Centers Participating
These centers are participating in this study. Reach out to them directly to learn more.
Registry entry updated 2023-09-13
Deciding whether to join a study is your choice, and you can ask a study team questions before you decide anything.
If you would rather we did it with you, call us on (656) 206-4686.