Comparing Early Surgery to Watchful Waiting for Adults with Severe Asymptomatic Aortic Valve Regurgitation

What this Trial Is About

Researchers are evaluating the best timing for surgery in patients who have severe aortic regurgitation but do not yet show symptoms. This heart valve condition often affects younger men and can lead to serious heart changes if left untreated. The study compares early surgery guided by detailed heart imaging with the usual approach of monitoring patients and operating only when symptoms or advanced heart changes develop. The study involves two main groups one will receive early, state-of-the-art aortic valve surgery, including valve-sparing procedures or replacements, scheduled within three months after randomization. The other group will follow a watchful waiting strategy with regular check-ups and surgery only if clear indications arise during follow-up. All patients undergo advanced heart imaging, exercise tests, blood tests, and quality of life questionnaires at set intervals. Participants will have heart magnetic resonance imaging and echocardiography at the start and at 12 months, plus clinical exams and tests every six months. Researchers will monitor heart function, exercise capacity, blood markers, and quality of life. The main outcome is a composite safety and effectiveness measure 12 months after randomization. The study also tracks complications, hospitalizations, and survival over time, with careful follow-up planned through the study duration.

Early Aortic vaLve surgEry Versus wAtchful waitiNg Strategy in Severe Asymptomatic aOrtic reguRgitation