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OpenTrials
Completed

NCT Number: NCT00256152

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

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.

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Key information

Conditions

Hypertension Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

McMaster University

Hamilton, Ontario, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

AF Suppression Pacing Algorithm

Device

Primary outcomes

  1. Composite of ischemic stroke & Non-CNS systemic embolism

    Time frame: 3 years

  2. Symptomatic or Asymptomatic AT documented by ECG

    Time frame: 3 years

Secondary outcomes

  1. Myocardial infarction [MI], Vascular death Composite of stroke, MI or vascular death

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Collaborators

  • Population Health Research Institute

Registry information

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Nov 21, 2005
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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