Status:
COMPLETED
Asymptomatic Atrial Fibrillation and Stroke Evaluation in Pacemaker Patients and the Atrial Fibrillation Reduction Atrial Pacing Trial
Lead Sponsor:
Abbott Medical Devices
Collaborating Sponsors:
Population Health Research Institute
Conditions:
Hypertension
Atrial Fibrillation
Eligibility:
All Genders
65+ years
Phase:
PHASE4
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 pa...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Age ≥ 65 years
- History of hypertension requiring pharmacological therapy (≥ 4 weeks of therapy).
- Recent (\< 8 weeks) St. Jude Medical Inc. pacemaker implant (IDENTITY® Adx DR (Model 5386/5380)), ICD implant (EPIC 2 or Atlas 2) or other St. Jude Medical Inc. pacemaker or ICD with the same capabilities.
- In pacemaker patients only the primary indication for pacing is sinus or AV node disease.
- Exclusion Criteria
- Previous documented AF, atrial flutter (lasting greater than 5 minutes), or other sustained SVT (not including episodes detected by the device)
- Geographic/social or psychiatric factor likely to interfere with follow-up
- Requirement for oral anticoagulation (heart valve, deep vein thrombosis, etc.)
Exclusion
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
2580 Patients enrolled
Trial Details
Trial ID
NCT00256152
Start Date
September 1 2004
End Date
June 1 2010
Last Update
February 4 2019
Active Locations (1)
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1
McMaster University
Hamilton, Ontario, Canada