Table 1.
Inclusion category | Inclusion definition |
---|---|
1. Drug-resistant symptomatic PAF | |
a. Paroxysmal | AF that terminates spontaneously or with intervention within 7 d of onset. |
b. Frequency | i. Physician documentation of recurrent PAF (2 or more episodes) within 6 mo, AND |
ii. At least 1 documented episode by a recording such as ECG, EM, Holter monitor or telemetry strip within 12 mo of enrollment. | |
c. Drug-resistant | Failed AAD treatment, meaning therapeutic failure of at least 1 AAD (class I to IV) for efficacy and/or intolerance |
2. Age | Patients who are ≥18 and ≤75 years of age on the day of enrollment. |
3. Participation | i. Providing informed consent to undergo study procedures, AND |
ii. Participating in all examinations and follow-up visits and tests associated with this clinical study. |
AAD = antiarrhythmic drug; AF = atrial fibrillation; ECG = electrocardiography; EM = event monitor; PAF = paroxysmal atrial fibrillation.