Clinical trial NCT00123344: Atrial Pacing for Termination and Prevention of Atrial Fibrillation
Official title: Atrial Pacing for Termination and Prevention of Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bradycardia
Atrial Fibrillation
Keywords: symptomatic bradycardia
paroxysmal atrial fibrillation
antitachycardia pacing therapies
prevention algorithms
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Ontario
First posted: 2005-07-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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 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

Primary outcomes:
measure: To determine the effects of antitachycardia pacing (ATP) therapies on prevention of atrial fibrillation recurrence over the long term
Secondary outcomes:
measure: To determine the effects of atrial pacing prevention algorithms on the time to recurrence of atrial fibrillation over the long term
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Hospital
state: Alberta
Study officials:
affiliation: University of Calgary, Professor of Medicine
name: Anne M Gillis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary, Professor of Medicine
name: D. George Wyse, MD, Ph.D
role: STUDY_CHAIR
affiliation: University of Calgary, Professor of Medicine
name: John M Rothschild, MD
role: STUDY_CHAIR
affiliation: University of Calgary, Statistician
name: M Sarah Rose, Ph D
role: STUDY_CHAIR
References: