Table 1.
Total number of investigational device recorded episodes that were reviewable. The total number of patients with true arrhythmia observed in any of those reviewable episodes.
| Group-A |
Group-B |
||
|---|---|---|---|
| Patients |
17 |
14 |
|
| Monitoring Duration | 24 h | 12 weeks | |
| Number of device recorded episodes with ECG (patients) | AT/AF | 33 (7) | 33 (7) |
| Bradycardia | 7 (3) | 37 (7) | |
| Pause | 198 (16) | 537 (13) | |
| Tachycardia | 24 (9) | 103 (13) | |
| Patient Activated | 0 (0) | 52 (11) | |
| Number of patients with true cardiac arrhythmia | AT/AF | 3 | 2 |
| Bradycardia/pause | 0 | 2 | |
| PVC | 0 | 3 | |
| Sinus Arrhythmia | 0 | 1 | |
| Sinus Tachycardia | 0 | 4 | |
| Junctional Rhythm | 1 | 0 |
| Device detected episode type | Group A – 24-h monitoring (N = 17 patients) |
Group B – 12-week monitoring (N = 14 patients) |
||||
|---|---|---|---|---|---|---|
| Number of detected episodes | Patients with detected episodes | Patients with true episodes | Number of detected episodes | Patients with detected episodes | Patients with true episodes | |
| AT/AF | 33 | 7 | 3 AF, 1 junctional rhythm |
33 | 7 | 2 AF |
| Bradycardia | 7 | 3 | 0 | 37 | 7 | 1 Bradycardia 1 pause |
| Pause | 198 | 16 | 0 | 537 | 13 | 0 |
| Tachycardia | 24 | 9 | 0 | 103 | 13 | 0 |
| Patient Activated | 0 | 0 | 0 | 52 | 12 | 3 PVC 4 sinus tachycardia 1 sinus arrhythmia |