The J-Valve Transfemoral Pivotal Study is testing a new heart valve system for people with severe aortic valve regurgitation (AR), a condition where blood flows backward into the heart. This study aims to assess if the J-Valve TF System is safe and beneficial for patients who cannot have traditional surgery. Eligible participants must have symptoms like shortness of breath due to AR and be considered high risk for surgery.

In the study, up to 194 participants from various countries will undergo a procedure using the J-Valve TF System. A smaller group will participate in a sub-study using Cardiac Magnetic Resonance (CMR), a special heart scan, to see how their heart changes after treatment and if it improves their quality of life.

• The study lasts for 5 years post-procedure, with regular follow-up visits required.
• Participants must sign a consent form and comply with the study's schedule.
• Participants should not have other serious heart valve issues or certain health conditions that conflict with the study.