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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:
Collaborator:
Population Health Research Institute
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00256152
First received: September 10, 2005
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Hypertension
Atrial Fibrillation
Device: AF Suppression Pacing Algorithm
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Asymptomatic Atrial Fibrillation and Stroke Evaluation in Pacemaker Patients and the Atrial Fibrillation Reduction Atrial Pacing Trial

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Composite of ischemic stroke & Non-CNS systemic embolism [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Symptomatic or Asymptomatic AT documented by ECG [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Myocardial infarction [MI], Vascular death Composite of stroke, MI or vascular death [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 2580
Study Start Date: September 2004
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: AF Suppression OFF
Experimental: AF Suppression ON Device: AF Suppression Pacing Algorithm

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00256152

Locations
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada
Sponsors and Collaborators
St. Jude Medical
Population Health Research Institute
Investigators
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
  More Information

No publications provided by St. Jude Medical

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00256152     History of Changes
Other Study ID Numbers: CRD291
Study First Received: September 10, 2005
Last Updated: July 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Medical:
Atrial fibrillation
Pacemaker
AF suppression pacing
Indications for Pacemaker Implantation due to sinus node or atrio-ventricular node disease

Additional relevant MeSH terms:
Atrial Fibrillation
Hypertension
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014