Stratos
1.7.3AVAIL and OVID Combined Primary Endpoint-Complication-free Rate (Safety)
The results from for the AVAIL CLS/CRT and OVID studies were pooled to evaluate the safety of the Stratos LV device. The safety of the Stratos LV was evaluated based on complications (adverse events that require additional invasive intervention to resolve) related to the implanted CRT system which includes the Stratos LV, the atrial lead, the right ventricular lead, the left ventricular lead and the implant procedure. The target
Table 12: OVID and AVAIL Complication-Free
Rate - Stratos LV
|
| Number | % of | Number of | Complications |
|
| Category | of | per patient- |
| ||
| Patients | Complications |
| |||
|
| Patients | year |
| ||
|
|
|
| |||
|
| LV |
|
| ||
| High |
| 1.8% |
|
|
|
| Threshold / No | 3 | 3 | 0.02 |
| |
| Capture |
|
|
|
|
|
| Diaphragmatic | 2 | 1.2% | 2 | 0.02 |
|
| Stimulation |
| ||||
|
|
|
|
|
| |
| Dislodgement | 1 | 1.2% | 2 | 0.01 |
|
| Total | 7 | 4.3% | 7 | 0.06 |
|
|
| RV Lead Related |
|
| ||
| High |
|
|
|
|
|
| Threshold / No | 9 | 5.5% | 9 | 0.07 |
|
| Capture |
|
|
|
|
|
| Total | 9 | 5.5% | 9 | 0.07 |
|
|
| Atrial Lead Related |
|
| ||
| No Capture | 1 | 0.6% | 1 | 0.01 |
|
| Total | 1 | 0.6% | 1 | 0.01 |
|