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

July 20, 2005
December 10, 2008
December 1999
June 2007   (final data collection date for primary outcome measure)
To determine the effects of antitachycardia pacing (ATP) therapies on prevention of atrial fibrillation recurrence over the long term
To determine the effects of antitachycardia pacing (ATP) therapies on prevention of atrial fibrillation recurrence over the long term.
Complete list of historical versions of study NCT00123344 on ClinicalTrials.gov Archive Site
To determine the effects of atrial pacing prevention algorithms on the time to recurrence of atrial fibrillation over the long term
To determine the effects of atrial pacing prevention algorithms on the time to recurrence of atrial fibrillation over the long term.
Not Provided
Not Provided
 
Atrial Pacing for Termination and Prevention of Atrial Fibrillation
Atrial Pacing for Termination and Prevention of Atrial Fibrillation

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Bradycardia
  • Atrial Fibrillation
Device: AT501 pacemaker
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
June 2007
June 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00123344
15099
Not Provided
Anne M. Gillis M.D., University of Calgary
University of Calgary
Heart and Stroke Foundation of Ontario
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
University of Calgary
December 2008

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