Atrial Pacing for Termination and Prevention of Atrial Fibrillation
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 1999
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 1999
CompletedFirst Submitted
Initial submission to the registry
July 20, 2005
CompletedFirst Posted
Study publicly available on registry
July 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedDecember 11, 2008
December 1, 2008
7.5 years
July 20, 2005
December 10, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine the effects of antitachycardia pacing (ATP) therapies on prevention of atrial fibrillation recurrence over the long term
Secondary Outcomes (1)
To determine the effects of atrial pacing prevention algorithms on the time to recurrence of atrial fibrillation over the long term
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Life expectancy \<3 years
- Unable to give informed consent
- Unable to come for followup
- Chronic AF
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Calgarylead
- Heart and Stroke Foundation of Ontariocollaborator
Study Sites (1)
Foothills Hospital
Calgary, Alberta, T2N 2T9, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne M Gillis, MD
University of Calgary, Professor of Medicine
- STUDY CHAIR
D. George Wyse, MD, Ph.D
University of Calgary, Professor of Medicine
- STUDY CHAIR
John M Rothschild, MD
University of Calgary, Professor of Medicine
- STUDY CHAIR
M Sarah Rose, Ph D
University of Calgary, Statistician
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 20, 2005
First Posted
July 22, 2005
Study Start
December 1, 1999
Primary Completion
June 1, 2007
Study Completion
June 1, 2007
Last Updated
December 11, 2008
Record last verified: 2008-12