J-VALVE Transcatheter Aortic Valve Replacement Versus Surgical Aortic Valve Replacement for Patients With Aortic Regurgitation Therapy
The overall purpose of ART trial is to establish the Safety and Efficacy of the J-VALVE Transcatheter Aortic Valve Replacement Versus Surgical Aortic Valve Replacement in Patients with Grade≥3+ Native Aortic Regurgitation.
• 1\) Age ≥65 years；
• 2\) a. Symptomatic patients with severe AR b. Asymptomatic patients with severe AR and evidence of LV function impairment (per current ESC / ACC guidelines) Any of the following perimeters
‣ LVEF ≤55%
⁃ LVESD \>50 mm
⁃ LVESDi \>22 mm/m2
⁃ LVESVi \>45 mL/m2
⁃ normal LV systolic function at rest (LVEF \>55%), and a progressive decline in LVEF on at least 3 serial studies to the low-normal range (LVEF 55% to 60%) or a progressive increase in LV dilation into the severe range (LV end-diastolic dimension \[LVEDD\] \>65 mm),
• 3\) Evaluated by a multi-disciplinary heart team to be suitable for both surgery and transcatheter valve replacement
• 4\) Informed of the nature of the study, agrees to its provisions, has provided written informed consent, and agrees to comply with all required post-procedure follow-up visits