J-Valve Transfemoral Pivotal Study
🔬 This trial is currently recruiting participants
If you match the criteria below, you may be able to take part. Ask your doctor about this trial or contact the trial team directly.
About This Trial
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.
Run by
JC Medical, Inc., an affiliate of Edwards Lifesciences LLC