In patients with a standard indication for pacing and no previous history of AF, detection of Atrial High Rate Episodes predicts an increased risk of stroke and systemic embolism.
Overdrive atrial pacing with the AF Suppression algorithm will reduce the risk of symptomatic AF in patients with standard indication for pacing and no previous history of AF.
- AF Suppression Pacing Algorithm Device
ARM 1: Kind: Experimental Label: AF Suppression ON
- Allocation: Randomized
- Masking: Open Label
- Purpose: Treatment
- Endpoint: Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Composite of ischemic stroke & Non-CNS systemic embolism||3 years||Yes|
|Primary||Symptomatic or Asymptomatic AT documented by ECG||3 years||Yes|
|Secondary||Myocardial infarction [MI], Vascular death Composite of stroke, MI or vascular death||3 years||Yes|