Computed Tomogram Myocardial Thickness Map Guided Pulmonary Vein Isolation vs. Empirical Pulmonary Vein Isolation in Cryoballoon Ablation for Paroxysmal Atrial Fibrillation (UTMOST AF II)

What this Trial Is About

Researchers are studying new ways to use radiofrequency energy for pulmonary vein isolation in patients with paroxysmal atrial fibrillation. This research aims to evaluate how personal differences in atrial tissue thickness, including variations due to age and sex, affect treatment safety and effectiveness. The study compares three methods: one guided by unipolar voltage subtraction maps, another using CT myocardial thickness maps, and the traditional empirical approach. Participants will be randomly assigned to one of three groups. Each group will undergo pulmonary vein isolation using a radiofrequency catheter with esophageal temperature monitoring to prevent injury. The first group uses unipolar voltage subtraction maps to adjust ablation time, the second group uses CT scans to guide energy delivery based on heart muscle thickness, and the third group receives treatment adjusted by the practitioner's experience. After the procedure, rhythm follow-ups will be conducted according to guidelines. Participants will be monitored at 1 week, 3 months, and every 6 months afterward, with ECGs and Holter monitoring to detect atrial fibrillation or tachycardia recurrence. Safety will be assessed by tracking procedure-related complications and major cardiovascular events within one year. Additional comparisons include procedure and ablation times, hospitalization length, and therapy-related complications. Follow-up may continue for up to three years to evaluate long-term outcomes.

Computed Tomogram Myocardial Thickness Map Guided pulmOnary Vein iSolaTion vs. Empirical Pulmonary Vein Isolation in Cryoballoon Ablation for Paroxysmal Atrial Fibrillation (UTMOST AF II)