Atrial Fibrillation Clinical Trial
Official title:
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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