Table 5.
Pivotal Trials of Leadless Pacing Devices.
| Trial | Year | Device | N | Mean Age | % Female | Follow-up | Primary Outcome | Implant Success Rate, n/N (%) | Complication Rate | Other |
|---|---|---|---|---|---|---|---|---|---|---|
| LEADLESS [121] | 2014 | NanoStim | 33 | 76.5 ± 8.4 | 33 | 3 m | 31/33 (94%) * | 32/33 (97%) | 3% (1 perforation requiring surgery; died of stroke) | 5 patients require > 1 LP during procedure |
| LEADLESS II [122] | 2015 | NanoStim | 526 | 75.8 ± 12.1 | 38.2 | 6 m | 270/300 (90.0%) † | 504/526 (95.8%) | 6.7% (22 events in 20 patients) | 1.7% dislodgements 1.3% tamponade 1.3% elevated thresholds |
| Micra IDE [123] | 2016 | Micra | 725 | 75.9 ± 10.9 | 41.2 | 6 m | 292/297 (98.3%) ‡ | 719/725 (99.2%) | 4.0% (28 events in 25 patients) | 1.6% perforation/effusion |
| LEADLESS II-Phase 2 [124] | 2022 | Aveir | 200 | 75.6 ± 11.3 | 37.5 | 6 w | 188/196 (95.9%) ¶ | 196/200 (98%) | 4.0% (9 events in 8 patients) | 1.5% tamponade |
* Freedom from complications at 90 days; † Composite of acceptable pacing threshold (≤2 V at 0.4 ms) and acceptable sensing amplitude (R wave ≥5 mV) through 6 months; ‡ Percentage of patients with low and stable pacing capture thresholds (≤2 V at 0.24 ms and an increase of ≤1.5 V from time of implant) at 6 months; ¶ Composite of acceptable pacing thresholds (≤2 V at 0.4 ms) and R wave amplitudes (≥5 mV or an equal or greater value at implantation) through 6 weeks.