Aortic Valve Disease Clinical Trial
Official title:
J-Valve TF Early Feasibility Study
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.
The EFS is a prospective, single arm, multi-center, interventional study that will enroll up to 15 subjects in up to 10 centers in the United States and/or Canada and report the primary endpoint of all-cause death or disabling stroke at 30 days. ;
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