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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00256152
First Posted: November 21, 2005
Last Update Posted: July 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Population Health Research Institute
Information provided by (Responsible Party):
St. Jude Medical
September 10, 2005
November 21, 2005
July 30, 2012
September 2004
June 2010   (Final data collection date for primary outcome measure)
  • Composite of ischemic stroke & Non-CNS systemic embolism [ Time Frame: 3 years ]
  • Symptomatic or Asymptomatic AT documented by ECG [ Time Frame: 3 years ]
  • Primary study outcome will be a composite of:
  • Ischemic stroke, Non-CNS systemic embolism
Complete list of historical versions of study NCT00256152 on ClinicalTrials.gov Archive Site
Myocardial infarction [MI], Vascular death Composite of stroke, MI or vascular death [ Time Frame: 3 years ]
  • Clinical documented atrial fibrillation or flutter
  • Myocardial infarction [MI], Vascular death Composite of stroke, MI or vascular death
Not Provided
Not Provided
 
Asymptomatic Atrial Fibrillation and Stroke Evaluation in Pacemaker Patients and the Atrial Fibrillation Reduction Atrial Pacing Trial
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Hypertension
  • Atrial Fibrillation
Device: AF Suppression Pacing Algorithm
  • No Intervention: AF Suppression OFF
  • Experimental: AF Suppression ON
    Intervention: Device: AF Suppression Pacing Algorithm

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2580
June 2010
June 2010   (Final data collection date for primary outcome measure)

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.)
Sexes Eligible for Study: All
65 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00256152
CRD291
Not Provided
Not Provided
Not Provided
St. Jude Medical
St. Jude Medical
Population Health Research Institute
Study Chair: Stuart Connolly, MD McMaster University
Study Chair: Stephan Hohnloser, MD Goethe University
Principal Investigator: Carlos Morillo, MD McMaster University
Principal Investigator: Jeff Healey, MD McMaster University
Principal Investigator: Carsten Israel, MD Goethe University
Principal Investigator: Michael Gold, MD Medical University of South Carolina
Principal Investigator: Chu-Pak Lau, MD The University of Hong Kong
Principal Investigator: Alessandro Capucci, MD Ospedale Clinic, Piacenza Italy
St. Jude Medical
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP