Atrial Fibrillation, Hypertension
Conditions
Keywords
Atrial fibrillation, Pacemaker, AF suppression pacing, Indications for Pacemaker Implantation due to sinus node or atrio-ventricular node disease
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.
Interventions
DEVICEAF Suppression Pacing Algorithm
Sponsors
Population Health Research Institute
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 65 years 2. History of hypertension requiring pharmacological therapy (≥ 4 weeks of therapy). 3. 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. 4. In pacemaker patients only the primary indication for pacing is sinus or AV node disease.
Exclusion criteria
1. Previous documented AF, atrial flutter (lasting greater than 5 minutes), or other sustained SVT (not including episodes detected by the device) 2. Geographic/social or psychiatric factor likely to interfere with follow-up 3. Requirement for oral anticoagulation (heart valve, deep vein thrombosis, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of ischemic stroke & Non-CNS systemic embolism | 3 years |
| Symptomatic or Asymptomatic AT documented by ECG | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Myocardial infarction [MI], Vascular death Composite of stroke, MI or vascular death | 3 years |
Countries
Canada
Outcome results
None listed