Table 2.
Primary safety endpoint
| Events through 30 days (n = 75) | Number of events, n (%) | Days after implant | Related to procedure | Related to study device | Therapy | Outcomes |
|---|---|---|---|---|---|---|
| Adverse events | ||||||
| Skin irritation | 1 (1.3) | 1 | Not related | Related | Clothing between reader and skin | Recovered without sequalae |
| Haemoptysis a | 1 (1.3) | 3 | Related | Related | None | Recovered without sequalae |
| Vessel trauma a | 1 (1.3) | 3 | Probably Related | Probably Related | Bronchoscopy | Recovered without sequalae |
| Haematoma | 1 (1.3) | 0 | Related | Not Related | None | Recovered without sequalae |
| Device‐related/system‐related complications | ||||||
| LV lead dislodgment a | 1 (1.3) | 0 | Related | Related | Lead revision | Recovered without sequalae |
| Serious adverse events | ||||||
| LV lead revision† | 1 (1.3) | 15 | Related | Related | Lead Replacement | Recovered without sequalae |
| Total Adverse Events | 6 (8.0) | |||||
LV, left ventricle.
a
Same patient.