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Atrial Pacing for Termination and Prevention of Atrial Fibrillation

This study has been completed.
Sponsor:
Collaborator:
Heart and Stroke Foundation of Ontario
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT00123344
First received: July 20, 2005
Last updated: December 10, 2008
Last verified: December 2008
History of Changes
  Purpose

Atrial fibrillation (AF) is the most common sustained arrhythmia and is associated with substantial morbidity and mortality. Present treatment strategies are aimed at termination of AF and prevention of AF recurrence using antiarrhythmic drugs or heart rate control drugs. Drugs are not always well tolerated, so atrial pacing as a strategy for prevention of atrial tachyarrhythmias is being explored.

The AT501 pacemaker has both "prevention" and "treatment" algorithms for atrial tachyarrhythmias. The investigators wish to determine whether these special features, over the long term, decrease the amount of time the person experiences AF.


Condition Intervention
Bradycardia
Atrial Fibrillation
 Device: AT501 pacemaker

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Atrial Pacing for Termination and Prevention of Atrial Fibrillation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • To determine the effects of antitachycardia pacing (ATP) therapies on prevention of atrial fibrillation recurrence over the long term

Secondary Outcome Measures:
  • To determine the effects of atrial pacing prevention algorithms on the time to recurrence of atrial fibrillation over the long term

Enrollment: 120
Study Start Date: December 1999
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Detailed Description:

There are some clinical and experimental data to suggest that atrial overdrive pacing should prevent AF. In our pacemaker population with tachy-brady syndrome, and in the PA3 study population, we observed that AF frequently clusters and may recur early following an episode of AF.

We are conducting a randomized trial of both prevention algorithms and antitachycardia pacing (ATP) therapies for the treatment of atrial tachyarrhythmias and thereby prevention of AF over the longterm.

Patients with a history of paroxysmal AF who received an AT501 pacemaker for the treatment of bradycardia will be randomized to having both the prevention and therapy algorithms "ON", both "OFF" or having only the therapy algorithms "ON". They will be followed every 3 months for 1 year, then every 6 months for an 2 additional years. Recurrence and frequency of AF will be determined over time based on data retrieved from the device at each follow-up visit.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Reason for pacing: symptomatic bradycardia
  • Paroxysmal AF (>5 min duration, >3 episodes) post implant of AT501 pacemaker
  • On stable antiarrhythmic drugs
  • Life expectancy >3 years

Exclusion Criteria:

  • Life expectancy <3 years
  • Unable to give informed consent
  • Unable to come for followup
  • Chronic AF
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00123344

Locations
Canada, Alberta
Foothills Hospital
Calgary, Alberta, Canada, T2N 2T9
Sponsors and Collaborators
University of Calgary
Heart and Stroke Foundation of Ontario
Investigators
Principal Investigator: Anne M Gillis, MD University of Calgary, Professor of Medicine
Study Chair: D. George Wyse, MD, Ph.D University of Calgary, Professor of Medicine
Study Chair: John M Rothschild, MD University of Calgary, Professor of Medicine
Study Chair: M Sarah Rose, Ph D University of Calgary, Statistician
  More Information

No publications provided

Responsible Party: Anne M. Gillis M.D., University of Calgary
ClinicalTrials.gov Identifier: NCT00123344     History of Changes
Other Study ID Numbers: 15099
Study First Received: July 20, 2005
Last Updated: December 10, 2008
Health Authority: Canada: Health Canada

Keywords provided by University of Calgary:
symptomatic bradycardia
paroxysmal atrial fibrillation
antitachycardia pacing therapies
prevention algorithms

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

ClinicalTrials.gov processed this record on October 16, 2012