Table 3.
Schedule of events, randomized subjects
| Assessment | Baseline∗ | Index procedure | Predischarge | Day 7 (7–11 d) | Day 30 (±7 d) | Day 60 (±10 d) | Day 90 (±14 d) | Month 6 (±30 d) | Month 12 (±30 d) | Unscheduled |
|---|---|---|---|---|---|---|---|---|---|---|
| Informed consent | X | |||||||||
| Baseline assessment | X | |||||||||
| TEE/ICE to exclude left atrial thrombus | X | |||||||||
| AAD and anticoagulant medications | X | X | X | X | Discontinue AADs |
X | X | X | X | |
| Recurrent arrhythmia, cardioversions, ablations, hospital admissions | X | X | X | X | X | X | X | |||
| Adverse events | X | X | X | X | X | X | X | X | ||
| 12-lead ECG | X | X | X | X | X | |||||
| Event monitors | Training | Training | Training | Weekly + symptomatic transmissions | X | |||||
| 72-h Holter | Training | Training | X | X | ||||||
| Cardiac CT/MRI | X | X | X† | |||||||
| NIHSS | X | X | ||||||||
| Radiological examination of diaphragm | X | X‡ | X‡ | |||||||
| AF symptom assessment | X | X | ||||||||
| QoL questionnaires | X | X | ||||||||
| Neurological assessment | X§ | X§ | ||||||||
| Assessment of subject blinding | X | X | ||||||||
AAD = antiarrhythmic drug; CT = computed tomography; ICE = intracardiac echocardiography; MRI = magnetic resonance imaging; NIHSS = National Institutes of Health Stroke Scale/Score; PV= pulmonary vein; QoL = quality of life; TEE = transesophageal echocardiography; TIA = transient ischemic attack; TTE = transthoracic echocardiography.
All baseline assessments must be generated in the window beginning 30 days (90 days for TTE and cardiac CT/MRI) prior to the consent date and ending on the date of the index procedure.
Month 12 cardiac MRI/CT only if 3-month imaging revealed any PV with ≥70% reduction in PV measured diameter.
Only if resolution of phrenic nerve palsy has not yet been demonstrated. May be performed either by fluoroscopic sniff test or inspiration/expiration chest radiography.
Non-Neurological Assessment Subgroupsubjects: If NIHSS score has increased by 1 or more points or if there is a clinical suspicion of stroke/TIA, then a consulting neurologist will perform a stroke assessment and include the results of a concurrent brain MRI. If stroke is diagnosed, a modified Rankin Scale assessment will be performed prior to discharge and again at 3 months.