Active, not recruitingNCT06034028

JVTF EFS

J-Valve TF Early Feasibility Study

JC Medical, Inc., an affiliate of Edwards Lifesciences LLCMultiple US sitesView on ClinicalTrials.gov

AI Description

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.

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Who can join
child, adult, older adult
Participants
25
Expected completion
2029-08-25
Funded by
industry

Conditions studied

Aortic Regurgitation, Aortic Valve Disease, Aortic Valve Insufficiency

What is being tested

  • DEVICE: J-Valve TF System

What it measures

  • Number of patients that do not experience death or disabling stroke, Freedom from death or disabling stroke Disabling stroke is evaluated using a standardized scale, 30 days after the valve procedure

Centers Participating

These centers are participating in this study. Reach out to them directly to learn more.

Data Sources and Methodology

Registry entry updated 2025-07-11

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.