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Atrial Pacing for Termination and Prevention of Atrial Fibrillation

NCT ID: NCT00123344

Last Updated: 2008-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-12-31

Study Completion Date

2007-06-30

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.

Conditions

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Bradycardia Atrial Fibrillation

Keywords

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symptomatic bradycardia paroxysmal atrial fibrillation antitachycardia pacing therapies prevention algorithms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Interventions

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AT501 pacemaker

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heart and Stroke Foundation of Ontario

OTHER

Sponsor Role collaborator

University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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University of Calgary

Principal Investigators

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Anne M Gillis, MD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary, Professor of Medicine

D. George Wyse, MD, Ph.D

Role: STUDY_CHAIR

University of Calgary, Professor of Medicine

John M Rothschild, MD

Role: STUDY_CHAIR

University of Calgary, Professor of Medicine

M Sarah Rose, Ph D

Role: STUDY_CHAIR

University of Calgary, Statistician

Locations

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Foothills Hospital

Calgary, Alberta, Canada

Site Status

Countries

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Canada

Other Identifiers

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15099

Identifier Type: -

Identifier Source: org_study_id