Table 2.
Clinical studies based on Implantable Loop Recorder findings.
Trial | Inclusion criteria | No therapy or pacemaker OFF arm | Pacemaker ON arm | Analysis | ||||||
---|---|---|---|---|---|---|---|---|---|---|
N | Female (%) | Mean age (years) | Recurrence of syncope | N | Female (%) | Mean age | Recurrence of syncope | |||
ISSUE 2 | ≥ 3 episodes in 2 years | 50 | 50 | 64 | 41% | 53 | 62 | 69 | 10% | Relative risk reduction 80%, p=0.002 |
ISSUE 3 | ≥ 3 episodes in 2 years | 39 | 59 | 63 | 57% | 38 | 47 | 63 | 25% | 57% relative reduction, p=0.039 |
N: number of patients.