Asymptomatic Atrial Fibrillation and Stroke Evaluation in Pacemaker Patients and the Atrial Fibrillation Reduction Atrial Pacing Trial

Completed

Phase 4 Results N/A

Trial Description

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.

Conditions

Interventions

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

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

Sponsors