| Safety | Freedom from major complicationsa related to the Micra transcatheter pacing system and/or procedures at 6-month post-implant (within 183 days) >83% |
| Efficacy | At the month 6 visit, >80% of subjects with a pacing capture threshold is low (≤2 V at a pulse width of 0.24 ms) and stable (increase of ≤1.5 V) |
| Safety | Freedom from major complicationsa related to the Micra transcatheter pacing system and/or procedures at 6-month post-implant (within 183 days) >83% |
| Efficacy | At the month 6 visit, >80% of subjects with a pacing capture threshold is low (≤2 V at a pulse width of 0.24 ms) and stable (increase of ≤1.5 V) |
aMajor complication is defined as any complication related to the Micra system or procedure that results in death, permanent loss of device function due to a mechanical or electrical malfunction, hospitalization, prolongation of hospitalization for 48 or more hours, or system change (removal, repositioning, or replacement).
| Safety | Freedom from major complicationsa related to the Micra transcatheter pacing system and/or procedures at 6-month post-implant (within 183 days) >83% |
| Efficacy | At the month 6 visit, >80% of subjects with a pacing capture threshold is low (≤2 V at a pulse width of 0.24 ms) and stable (increase of ≤1.5 V) |
| Safety | Freedom from major complicationsa related to the Micra transcatheter pacing system and/or procedures at 6-month post-implant (within 183 days) >83% |
| Efficacy | At the month 6 visit, >80% of subjects with a pacing capture threshold is low (≤2 V at a pulse width of 0.24 ms) and stable (increase of ≤1.5 V) |
aMajor complication is defined as any complication related to the Micra system or procedure that results in death, permanent loss of device function due to a mechanical or electrical malfunction, hospitalization, prolongation of hospitalization for 48 or more hours, or system change (removal, repositioning, or replacement).
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