Table 1:
Stage | Stopping Rules | |
---|---|---|
Stage 1 | AV Block Cycle Length | Met Primary End Point (protocol completed) |
AV Node ERP (S1: 600) | ||
Atrial ERP (S1: 600) | ||
AV Node ERP (S1: 450) | ||
Atrial ERP (S1: 450) | ||
Stage 2 | 15-beat Atrial Burst at 250ms | Met Primary End Point (protocol completed) OR Lost 1:1 atrial capture (proceed to Stage 3) |
15-beat Atrial Burst at 240ms | ||
15-beat Atrial Burst at 230ms | ||
15-beat Atrial Burst at 220ms | ||
15-beat Atrial Burst at 210ms | ||
15-beat Atrial Burst at 200ms | ||
15-beat Atrial Burst at 1900ms | ||
15-beat Atrial Burst at 180ms | ||
Stage 3 | #1 15-second* Atrial Burst | Met Primary End Point (protocol completed) |
#2 15-second* Atrial Burst | ||
#3 15-second* Atrial Burst | ||
#4 15-second* Atrial Burst | ||
#5 15-second* Atrial Burst | ||
End Protocol | No sustained AF/AT/AFL induced |
The cycle length used for Stage 3 was the shortest cycle length (fastest pacing) that had 1:1 atrial conduction