J-Valve Transfemoral Pivotal Study

The primary objective of this study is to assess the safety and efficacy of the J-Valve Transfemoral (TF) System in patients with symptomatic, severe (grade 3 or 4), native aortic valve regurgitation (AR) and AR-dominant mixed aortic valve disease, who are judged by a multi-disciplinary heart team to be at high risk for open surgical aortic valve replacement (SAVR). A Cardiac Magnetic Resonance (CMR) sub-study will examine if intervention for AR translates to improved ventricular remodeling, the impact of LV remodeling on clinical outcomes and quality of life, as well as volumetric and myocardial differences between genders.

NCT Number	NCT06455787
Lead Sponsor	JC Medical, Inc., an affiliate of Edwards Lifesciences LLC Collaborators: Minneapolis Heart Institute Foundation, Cardiovascular Research Foundation, New York
Conditions	Aortic Valve Regurgitation, Aortic Valve Disease Mixed
Enrollment	194 participants
Start Date	2024-10-17
Primary Completion	2028-02 (estimated)
Study Completion	2032-02 (estimated)
Updated on ClinicalTrials.gov	2026-05-04