Comparing Standard and Optimized Balloon Expansion Techniques During Transcatheter Aortic Valve Implantation to Reduce Valve Leaflet Thickening in Patients Without Atrial Fibrillation

What this Trial Is About

Researchers are evaluating an optimized expansion strategy for transcatheter aortic valve implantation TAVI in patients without atrial fibrillation who have severe native aortic valve stenosis. The study compares this optimized method, which involves systematic pre- and post-dilatation of the implanted valve, against the standard of care TAVI approach. The goal is to assess whether the optimized technique better reduces hypoattenuating leaflet thickening, a condition measured by cardiac computed tomography CT imaging three months after TAVI. Participants will be randomly assigned to one of two groups the standard of care TAVI group, where pre- and post-dilatation are optional and decided by the operator, or the optimized expansion TAVI group, where systematic pre- and post-dilatation are performed with an optimally sized balloon. The balloon size is based on specific measurements of the native aortic annulus. Both groups undergo the TAVI procedure using either self-expanding or balloon-expandable valves, with post-dilatation encouraged only under certain conditions in the standard care group. During the study, patients will have baseline assessments including medical history, electrocardiogram, echocardiography, and cardiac CT scans. Follow-up visits are scheduled at hospital discharge, and at approximately 3 months, 1 year, and 5 years post-procedure. At these visits, transthoracic echocardiography and various imaging studies like cardiac CT or PET-CT scans will evaluate valve leaflet thickening, valve performance, and other health outcomes. The primary outcome focuses on leaflet thickening at three months, with multiple secondary outcomes assessed up to five years to monitor valve function and patient safety.

Optimized Expansion of the Implanted Transcatheter Aortic Valve