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Atrial Pacing for Termination and Prevention of Atrial Fibrillation

Atrial Pacing for Termination and Prevention of Atrial Fibrillation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00123344
Enrollment
120
Registered
2005-07-22
Start date
1999-12-31
Completion date
2007-06-30
Last updated
2008-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Bradycardia

Keywords

symptomatic bradycardia, paroxysmal atrial fibrillation, antitachycardia pacing therapies, prevention algorithms

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.

Interventions

DEVICEAT501 pacemaker

Sponsors

Heart and Stroke Foundation of Ontario
CollaboratorOTHER
University of Calgary
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026