Comparing J-VALVE Transcatheter and Surgical Aortic Valve Replacement in Patients Aged 65 and Older with Severe Aortic Regurgitation

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the J-VALVE Transcatheter Aortic Valve Replacement TAVR compared to traditional Surgical Aortic Valve Replacement SAVR in patients aged 65 and older with severe aortic regurgitation Grade 3. This study aims to determine which method better manages this heart valve condition, focusing on important health outcomes such as survival and hospital readmissions. Participants will be randomly assigned to receive either the J-VALVE Transfemoral Aortic Valve system through a catheter-based procedure or a commercially available surgical biological aortic valve replacement device through open-heart surgery. Both approaches are performed by specialized heart teams, and treatment suitability is assessed carefully before enrollment. During the study, participants will be closely monitored for up to 12 months to track outcomes like mortality, stroke, and unplanned cardiac hospitalizations. Additional assessments within 30 days will include heart rhythm changes, valve function via echocardiography, quality of life questionnaires, and hospitalization length. Follow-up visits and evaluations will ensure comprehensive safety and effectiveness data collection throughout the trial period.

ART Trial: Transcatheter J-VALVE Versus Surgery for Aortic Regurgitation Therapy