Table 2. Efficacy endpoint between procedures in different patterns of population.
MIPDO (n/N) | Surgical (n/N) | Difference between groups (two-sided 95% CI) | |
---|---|---|---|
ITT population | 49/50 (98%) | 49/50 (98%) | 0 (−0.055 to 0.055)* |
PP population | 49/49 (100%) | 50/51 (98%) | 0.02 (−0.018 to 0.058)* |
*, showing non-inferiority of perventricular to surgical closure. n, population with echocardiography-confirmed complete VSD closure; N, population in the different patterns of the predefined population; ITT, intention-to-treat; PP, per-protocol.