Vision-MR Ablation Catheter 2.0 Treatment for Type I Atrial Flutter Using iCMR Guidance

What this Trial Is About

Researchers are evaluating the safety and effectiveness of radiofrequency RF ablation treatment for type I atrial flutter using the Vision-MR Ablation Catheter 2.0 in an interventional cardiac magnetic resonance iCMR environment. This prospective, single-arm, multi-center clinical trial aims to gather data on how well this device works and how safe it is for patients with this heart rhythm disorder. The study involves performing type I atrial flutter ablation using the Vision-MR Ablation Catheter 2.0 together with the Advantage-MR EP recorder and stimulator system within the iCMR setting. Participants will receive this treatment during the procedure, which is guided by magnetic resonance imaging to target the affected heart area precisely. Participants will be monitored during and after the procedure to confirm successful blockage of arrhythmia pathways and to track any serious cardiovascular adverse events up to 7 days post-procedure. Further follow-up at 90 days will evaluate the continued absence of atrial flutter episodes and monitor for any serious adverse events throughout the study duration. The trial will assess these clinical outcomes to understand the efficacy and safety of the RF ablation device.

Atrial Flutter Ablation in the iCMR