Study of Coronary Re-Engagement After Random Navitor Valve Implantation Compared to Commissural Alignment Technique in Aortic Valve Stenosis Patients Undergoing TAVR

What this Trial Is About

Researchers are investigating the feasibility of coronary re-engagement after transcatheter aortic valve implantation TAVI in patients with severe aortic stenosis. The study compares a simpler procedure using a random implantation of the Navitor valve without commissural alignment against the commissural alignment technique currently used to improve coronary re-access. This research addresses the importance of easy coronary re-engagement due to the prevalence of coronary artery disease and the increasing number of younger patients undergoing TAVI. The study involves two groups one receiving TAVI with the commissural alignment technique using Accurate or Accurate Neo 2 valves, and another group receiving TAVI with random implantation of the Navitor valve. The research evaluates success rates and procedure complexity by considering factors such as radiation exposure, procedure time, and contrast use during the interventions. The goal is to determine if the simpler Navitor implantation is not inferior in terms of coronary re-access. Participants will undergo assessments during the procedure to measure coronary re-access success and various secondary outcomes, including implant time, fluoroscopy time, radiation exposure, contrast usage, and re-engagement time. These measurements aim to provide detailed data on the feasibility and complexity of coronary re-engagement across the two implantation techniques. The study will continue until May 2027 and is observational, focusing on real-world procedural outcomes.

COronary Re-engageMent aFter randOm NavitoR alignmenT (COMFORT STUDY)