A prospective, multicenter, single-arm study of performance of the micra transcatheter pacemaker in chinese patients: A comparison to the global experience

Safety and Performance of the Micra VR Leadless Pacemaker in a Japanese Cohort ― Comparison With Global Studies ―

“…The primary endpoint of this study was the safety of the Micra VR system in a Japan-specific population as indicated by the acute major complication rate. Acute major complications were defined as adverse events related to the interquartile range: 14-36 min) compared with IDE (28.0 min; interquartile range: 21-41 min) and PAR (26.0 min; interquartile range: 19-40 min) (P=0.006), but median fluoroscopy time was longer (9.5 min [6][7][8][9][10][11][12][13][14][15] vs. 6.0 min [4][5][6][7][8][9][10] vs. 6.6 min [4][5][6][7][8][9][10][11], respectively; P<0.001). A majority (66.9%) of MAP Japan patients required only 1 deployment, and the device was implanted within the septum in 87.7% of cases.…”