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

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ClinicalTrials.gov Identifier: NCT00256152
Recruitment Status : Completed
First Posted : November 21, 2005
Last Update Posted : February 4, 2019
Sponsor:
Collaborator:
Population Health Research Institute
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date  ICMJE September 10, 2005
First Posted Date  ICMJE November 21, 2005
Last Update Posted Date February 4, 2019
Study Start Date  ICMJE September 2004
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2011)
  • Composite of ischemic stroke & Non-CNS systemic embolism [ Time Frame: 3 years ]
  • Symptomatic or Asymptomatic AT documented by ECG [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 17, 2005)
  • Primary study outcome will be a composite of:
  • Ischemic stroke, Non-CNS systemic embolism
Change History Complete list of historical versions of study NCT00256152 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2011)
Myocardial infarction [MI], Vascular death Composite of stroke, MI or vascular death [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2005)
  • Clinical documented atrial fibrillation or flutter
  • Myocardial infarction [MI], Vascular death Composite of stroke, MI or vascular death
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Asymptomatic Atrial Fibrillation and Stroke Evaluation in Pacemaker Patients and the Atrial Fibrillation Reduction Atrial Pacing Trial
Official Title  ICMJE Asymptomatic Atrial Fibrillation and Stroke Evaluation in Pacemaker Patients and the Atrial Fibrillation Reduction Atrial Pacing Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension
  • Atrial Fibrillation
Intervention  ICMJE Device: AF Suppression Pacing Algorithm
Study Arms  ICMJE
  • No Intervention: AF Suppression OFF
  • Experimental: AF Suppression ON
    Intervention: Device: AF Suppression Pacing Algorithm
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 27, 2012)
2580
Original Enrollment  ICMJE
 (submitted: November 17, 2005)
2500
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00256152
Other Study ID Numbers  ICMJE CRD291
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Abbott Medical Devices
Study Sponsor  ICMJE Abbott Medical Devices
Collaborators  ICMJE Population Health Research Institute
Investigators  ICMJE
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
PRS Account Abbott Medical Devices
Verification Date February 2019

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