Comparing the JenaValve Trilogy Transcatheter Heart Valve System with Surgical Valve Replacement for Treating Aortic Regurgitation

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the Trilogy Transcatheter Heart Valve THV System compared with traditional surgical aortic valve replacement SAVR in patients with significant native aortic regurgitation AR. The trial aims to show that the Trilogy THV system is not inferior to SAVR for treating this heart valve condition, which causes the aortic valve to leak, leading to symptoms and heart complications. Participants are randomly assigned to receive either the Trilogy THV device via transcatheter aortic valve replacement TAVR or a commercially available surgical prosthetic valve through SAVR. These two treatment groups allow comparison between the less invasive TAVR procedure and traditional open-heart surgery. The study involves monitoring participants for outcomes related to mortality, stroke, rehospitalization, and valve function at several time points. Throughout the trial, participants will return for follow-up visits where heart function is assessed using echocardiography and questionnaires about symptoms and quality of life are completed. Researchers will track important health events such as strokes, atrial fibrillation, and rehospitalizations for up to 12 months or longer. The total study duration extends through 2036, with primary outcomes assessed at 12 months and additional long-term monitoring for adverse cardiovascular events.

ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™