Non-Invasive CT Scan Versus Invasive Coronary Angiography to Check Heart Artery Disease Before Transcatheter Aortic Valve Replacement in Adults with Severe Aortic Stenosis

What this Trial Is About

This research aims to evaluate whether a non-invasive coronary artery disease CAD assessment using photon-counting detector computed tomography PCD-CT is as safe and effective as the current standard invasive coronary angiography ICA before transcatheter aortic valve replacement TAVR in patients with severe aortic stenosis. The study tests if the PCD-CT approach is not worse than ICA in terms of major adverse cardiovascular events MACE occurring within 12 months. Participants are randomly assigned to one of two groups. One group will have their CAD assessed by PCD-CT, and ICA will only be done if significant CAD is detected by PCD-CT. The other group will receive routine ICA as part of standard care before TAVR. The trial is conducted across multiple centers with a randomized, single-blind design. During the study, participants will be monitored for up to 12 months after randomization to measure major adverse cardiovascular events, including death, heart attacks, strokes, urgent heart procedures, or bleeding. Researchers will collect data on these outcomes and other cardiovascular events to compare the two assessment strategies. Participants will be followed closely to ensure safety and to gather comprehensive information about the effectiveness of the diagnostic methods.

Assessment of Coronary Artery Disease Before Transcatheter Aortic Valve Replacement: A Randomized, Multicenter, Non-Inferiority Trial