Atrial Pacing for Termination and Prevention of Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

Atrial Pacing for Termination and Prevention of Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00123344
• Other study ID #: 15099
• Status: Completed
• Phase: N/A
• First received: July 20, 2005
• Last updated: December 10, 2008
• Start date: December 1999
• Est. completion date: June 2007

Study information

• Verified date: December 2008
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Bradycardia

Intervention

Device:
• AT501 pacemaker

Locations

Country	Name	City	State
Canada	Foothills Hospital	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	Heart and Stroke Foundation of Ontario

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the effects of antitachycardia pacing (ATP) therapies on prevention of atrial fibrillation recurrence over the long term
Secondary	To determine the effects of atrial pacing prevention algorithms on the time to recurrence of atrial fibrillation over the long term