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OpenTrials
Completed

NCT Number: NCT00123344

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.

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Key information

Conditions

Bradycardia Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foothills Hospital

Calgary, Alberta, T2N 2T9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AT501 pacemaker

Device

Primary outcomes

  1. To determine the effects of antitachycardia pacing (ATP) therapies on prevention of atrial fibrillation recurrence over the long term

Secondary outcomes

  1. To determine the effects of atrial pacing prevention algorithms on the time to recurrence of atrial fibrillation over the long term

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Heart and Stroke Foundation of Ontario

Registry information

Important dates

Study start
1999
Primary completion
2007
Study completion
2007
First posted
Jul 22, 2005
Registry last updated
Dec 11, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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