Optimization of Commissural Alignment During Transcatheter Aortic Valve Implantation With Evolut FX+

Purpose of the Study The purpose of this study is to investigate how a transcatheter aortic valve (TAVI, biological valve prosthesis) can best be positioned in order to avoid blockage of the coronary arteries by the valve material after implantation. Method The study will include patients undergoing TAVI. Participants will be randomized, meaning that it will be determined by chance which of two established implantation techniques is used. Both techniques are already part of routine clinical practice. Examinations After the procedure, a CT scan will be performed to evaluate the position of the valve in relation to the coronary arteries. This CT scan is the only additional examination beyond today's standard clinical practice. Significance If one of the techniques proves to provide better positioning of the valve, this method may be recommended as standard practice in future treatment. The study will therefore contribute to improved patient safety and treatment quality, as well as increase knowledge about optimal positioning and implantation techniques in TAVI.

NCT Number	NCT07217691
Lead Sponsor	Oslo University Hospital
Conditions	Aortic Stenosis, Trans-catheter Aortic Valve Implantation, Commissural Alignment
Enrollment	40 participants
Start Date	2025-11-01
Primary Completion	2026-05-01 (estimated)
Study Completion	2026-05-01 (estimated)
Updated on ClinicalTrials.gov	2025-10-16