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26 Stratos LV/LV-T Technical Manual
Table 2: Atrial Fibrillation Demographics at Enrollment
Characteristic Group 1 Group 2 Group 3 P-value*
Rate Control
Medication,
Reasons for
Discontinuation
Ineffective
Not tolerated
Other
N=17
10 (58.8%)
8 (47.1%)
1 (5.9%)
N=20
13 (65.0%)
7 (35.0%)
2 (10.0%)
N=12
9 (75.0%)
3 (25.0%)
0 (0.0%)
0.558
0.760
0.800
Rhythm Control
Medication,
Reasons for
Discontinuation
Ineffective
Not tolerated
Other
N=22
17 (77.3%)
6 (27.3%)
1 (4.5%)
N=25
20 (80.0%)
7 (28.0%)
1 (4.0%)
N=13
8 (61.5%)
6 (46.2%)
2 (15.4%)
0.759
0.530
0.430
Cardioversion
History
Successful prior
electrical
cardioversion
Transthoracic
Transvenous
Unsuccessful prior
electrical
cardioversion
Transthoracic
Transvenous
No electrical
cardioversion
attempted
Successful prior
pharmacological
cardioversion
Unsuccessful prior
pharmacological
cardioversion
No pharmacological
cardioversion
attempted
N=42
13 (31.0%)
13 (100.0%)
0 (0.0%)
15 (35.7%)
15 (100.0%)
0 (0.0%)
17 (40.5%)
5 (11.9%)
8 (19.0%)
23 (54.8%)
N=49
16 (32.7%)
15 (93.8%)
1 (6.3%)
14 (28.6%)
14 (93.3%)
2 (13.3%)
20 (40.8%)
3 (6.1%)
11 (22.4%)
29 (59.2%)
N=25
10 (40.0%)
10 (100.0%)
0 (0.0%)
7 (28.0%)
7 (100.0%)
0 (0.0%)
9 (36.0%)
3 (12.0%)
7 (28.0%)
15 (60.0%)
0.760
0.808
0.680
0.741
0.936
0.547
0.678
0.915
*Chi-Square test (2-sided)
- Stratos 1
- Contents 3
- 1. General 9
- 1.2 Indications 10
- 1.3 Contraindications 11
- 1.4 Note to Physician 11
- 1.5.5 Home Monitoring 19
- 1.5.8 Cellular Phones 22
- 1.7 Clinical Studies 25
- P-value 31
- *Chi-Square test (2-sided) 34
- VES (n=2) 50
- OPTION CRT/ATx 57
- 34 (25.6%) 63
- 19 (28.4%) 63
- 36 (27.1%) 63
- 14 (20.9%) 63
- 2. Programmable Parameters 71
- 2.1.3 DDI 75
- 2.1.4 DVI 75
- 2.1.5 VDD 75
- 2.1.6 AAI and VVI 76
- 2.1.7 AAI, VVI 76
- 2.1.8 AOO, VOO 76
- 2.1.9 DOO 76
- 2.1.10 VDI 76
- Stratos CRT-Ps 77
- 2.3 Timing Functions 78
- 2.3.3 Scan Hysteresis 80
- 2.3.4 Repetitive Hysteresis 82
- 2.3.5 Night Mode 83
- 2.3.6 Refractory Periods 84
- 2.3.7 Atrial PMT Protection 85
- 2.3.9 AV Delay 86
- 2.3.11 Sense Compensation 88
- 2.3.13 Safety AV Delay 89
- 2.5 Automatic Lead Check 92
- 2.7 Wenckebach 2:1 94
- 2.8 Mode Switching 96
- 2.9 PMT Management 97
- 2.9.2 PMT Detection 98
- 2.11 Atrial Upper Rate 100
- (Overdrive Mode) 100
- CAUTION 102
- 2.14.2 Sensor Gain 104
- 2.14.3 Automatic Sensor Gain 104
- 2.14.4 Sensor Threshold 105
- 2.14.5 Rate Increase 105
- 2.15 Sensor Stimulation 106
- 2.16 Rate Fading 107
- 2.17.2 Patient Device 111
- 2.17.3 Transmitting Data 111
- 2.18 Statistics 117
- Statistics 118
- 2.20 Timing Statistics 119
- 2.20.3 Rate Trend 120
- 2.21 Arrhythmia Statistics 121
- 2.21.3 AES Statistics 122
- 2.21.4 VES Statistics 123
- 2.22 Sensor Statistics 124
- 2.23 Sensing Statistics 125
- 2.24 Pacing Statistics 126
- 3. Follow-up Procedures 127
- 4. Real-Time IEGM 129
- 5. Battery, Pulse and Lead 131
- Sensing Function 132
- 5.4 Non-Invasive Programmed 133
- Stimulation (NIPS) 133
- 5.4.5 NIPS Safety Features 135
- 6. Other Functions/Features 137
- 6.2 Patient Data Memory 138
- 6.3 Safe Program Settings 138
- 6.4 Magnet Effect 139
- 6.5 Position Indicator 139
- 6.6 Pacing When Exposed to 140
- Interference 140
- 7. Product Storage and 143
- Handling 143
- 8. Lead Connection 147
- 8.2 Lead Connection 148
- Bipolar lead in right atrium 150
- 9. Elective Replacement 153
- Indication (ERI) 153
- WARNING 155
- 10. Explantation 157
- 11. Technical Data 159
- 11.5 Additional Functions 165
- 11.6 Programmers 166
- Synchronization 167
- 11.10 Mechanical Data 168
- 12. Order Information 169
- Appendix A 171
- Distributed by: 172
- Manufactured by: 172
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