CompletedPhase 4

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

Canada2,580 participantsStarted 2004-09

Plain-language 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.

Who can participate

Age range65 Years

SexALL

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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.)

What they're measuring

Composite of ischemic stroke & Non-CNS systemic embolism

Timeframe: 3 years

Symptomatic or Asymptomatic AT documented by ECG

Timeframe: 3 years

Trial details

NCT IDNCT00256152

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-06

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