Atrial Pacing for Termination and Prevention of Atrial Fibrillation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Atrial Pacing for Termination and Prevention of Atrial Fibrillation

Conditions
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Bradycardia, Atrial Fibrillation

Intervention / Treatment
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* Device: AT501 pacemaker


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: AT501 pacemaker|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effects of antitachycardia pacing (ATP) therapies on prevention of atrial fibrillation recurrence over the long term |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effects of atrial pacing prevention algorithms on the time to recurrence of atrial fibrillation over the long term |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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symptomatic bradycardia, paroxysmal atrial fibrillation, antitachycardia pacing therapies, prevention algorithms