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

Phase 4

Completed

• Conditions: Atrial Fibrillation; Hypertension
• Interventions: Device: AF Suppression Pacing Algorithm

• Registration Number: NCT00256152
• Lead Sponsor: Abbott Medical Devices

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-09-10
• Study First Submitted QC: 2005-11-17
• Study First Posted: 2005-11-21
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2580

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AF Suppression ON	AF Suppression Pacing Algorithm	-

Primary Outcome Measures

Name	Time	Method
Composite of ischemic stroke & Non-CNS systemic embolism	3 years
Symptomatic or Asymptomatic AT documented by ECG	3 years

Secondary Outcome Measures

Name	Time	Method
Myocardial infarction [MI], Vascular death Composite of stroke, MI or vascular death	3 years

Trial Locations

Locations (1)

McMaster University; 🇨🇦 Hamilton, Ontario, Canada