Grant: Project Grant

Moderate aortic stenosis (MAS) poses a significant risk for adverse heart events and can quickly progress to severe AS. Currently, no treatments are available specifically for MAS unless a patient is already undergoing heart surgery for another reason. No medication has been proven to stop MAS from worsening, and surgical valve replacements carry risks like complications and valve failure, highlighting the urgent need for new treatment options. Non-Invasive Ultrasound Therapy (NIUT) is emerging as a promising, non-surgical approach to treating aortic stenosis. This therapy uses ultrasound waves to target and treat the heart valve without the need for invasive surgery. The VALVOSOFT MAS trial aims to evaluate the safety and effectiveness of NIUT in slowing the progression of MAS. This is a prospective, double-blind, randomized clinical trial involving 386 MAS patients. Participants will be randomly assigned to either the Active Arm, receiving therapeutic ultrasound, or the Control Arm, receiving subtherapeutic ultrasound. The primary outcome of the study is the change in aortic valve orifice area over three years, which will determine the therapy's effectiveness. The main trial is funded by the French Government. The purpose of the present CIHR application is to include a cohort of patients in Canada and to support the imaging (echocardiography and CT) core laboratories that will be based at Québec Heart & Lung Institute for the French and Canadian cohorts. If successful, this study could revolutionize the treatment of MAS by offering a non-invasive, repeatable therapy that does not require valve replacement. NIUT could provide a safer and more effective option compared to current treatments, with the potential for multiple applications if the condition progress over time.