Clinical Trial

J-Valve TF Early Feasibility Study

Study acronym: JVTF EFS
Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
The main objective of this study is to assess the preliminary safety and effectiveness of the J-Valve TF System in patients with symptomatic severe native aortic regurgitation who are judged by a multi-disciplinary heart team to be eligible for the device and to be at high risk for open surgical aortic valve replacement.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2023-09-05; most recent amendment 2025-07-09.
Status change: Recruiting → Active, Not Recruiting 2024-07-18
Status change: Not Yet Recruiting → Recruiting 2023-11-09
Trial Details
NCT Number NCT06034028
Lead Sponsor JC Medical, Inc., an affiliate of Edwards Lifesciences LLC
Conditions Aortic Valve Disease, Aortic Valve Insufficiency, Aortic Regurgitation
Enrollment 25 participants
Start Date 2023-10-16
Primary Completion 2024-07-17 (estimated)
Study Completion 2029-08-25 (estimated)
Updated on ClinicalTrials.gov 2025-07-11