Table 2.
Baseline characteristics, safety population analysis set (n = 140)
| n = 140 | |
|---|---|
| Age, mean (SD), years | 61.6 (7.8) |
| Male, n (%) | 80 (57.1) |
| CHA2DS2-VASc score, mean (SD) | 1.8 (1.3) |
| Diagnosis to ablation time, mean (SD), months | 53.1 (61.8) |
| Direct current cardioversion in past 12 months for paroxysmal AF, n (%) | 34 (24.3) |
| History of typical right atrial flutter, n (%) | 13 (9.3) |
| LVEF, mean (SD), % | 56.9 (5.9) |
| LA diameter, mean (SD), mm | 39.5 (5.3) |
| Failed Class I/III antiarrhythmic drug(s) at baseline, n (%) | 83 (59.3) |
| Failed Class II/IV antiarrhythmic drug(s) at baseline, n (%) | 112 (80.0) |
| Cardiovascular medical history, n (%) | 103 (73.6) |
| Hypertension | 76 (54.3) |
| Coronary disease | 22 (15.7) |
| Congestive heart failure Class II | 6 (4.3) |
| Prior thromboembolic events, n (%) | 7 (5.0) |
| Diabetes type 2, n (%) | 10 (7.1) |
| Obstructive sleep apnoea, n (%) | 6 (4.3) |
AF, atrial fibrillation; CHA2DS2-VASc, congestive heart failure; hypertension; age ≥75 years (doubled); type 2 diabetes; previous stroke or thromboembolism (doubled); vascular disease; age 65–75 years; and sex category; LA, left atrial; LVEF, left ventricular ejection fraction; SD, standard deviation.