TABLE 2.

Primary and secondary endpoints in the ISOLATION study.

Primary endpoint
Ablation success, defined as freedom from documented recurrence of atrial arrhythmia after 12 months. Recurrences in the first 3 months after the index procedure (blanking period) are exempted.
Secondary endpoints
Time to recurrence of atrial arrhythmia after the blanking period;
Time to recurrence of AF after the blanking period;
Freedom from documented recurrence of atrial arrhythmia after 24 months. Recurrences in the blanking period are exempted;
Early AF recurrences, defined as any episode of AF during the blanking period;
Early recurrences of atrial arrhythmia, defined as any episode of AF, atrial tachycardia or non-isthmus dependent atrial flutter during the blanking period;
Disease progression to persistent or permanent AF;
Changes in circulating biomarkers and non-invasive electrophysiological markers for substrate quantification;
Use of antiarrhythmic drugs 1 year after ablation;
Redo procedures, defined as repeated ablation procedure with the goal to prevent recurrence of AF or reduce the AF burden after one or more previous attempts to achieve the same goal;
Number of veins with pulmonary vein reconnection at redo procedure;
Major adverse cardiovascular events.