BradycardiaNCT00123344
Atrial Pacing for Termination and Prevention of Atrial Fibrillation
A study testing AT501 pacemaker in people with Bradycardia and Atrial Fibrillation, run by University of Calgary at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradycardia, Atrial Fibrillation
- What is being tested?
- AT501 pacemaker
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Dec 1999to Jun 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Life expectancy <3 years
- Unable to give informed consent
- Unable to come for followup
- Chronic AF
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Bradycardia, Atrial Fibrillation
- Being tested
- AT501 pacemaker
- Keywords
- symptomatic bradycardia, paroxysmal atrial fibrillation, antitachycardia pacing therapies, prevention algorithms
- Medical subject headings
- Bradycardia, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AT501 pacemakerDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2005 (estimated)
- Study startDec 1999
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BradycardiaStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Ontario
- Investigators
- Anne M Gillis, MD, Principal investigator, University of Calgary, Professor of MedicineD. George Wyse, MD, Ph.D, Study chair, University of Calgary, Professor of MedicineJohn M Rothschild, MD, Study chair, University of Calgary, Professor of MedicineM Sarah Rose, Ph D, Study chair, University of Calgary, Statistician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00123344
- Sponsor's protocol ID
- 15099
- Status last verified
- Dec 2008
- First submitted
- 20 Jul 2005
- Last updated
- 11 Dec 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Pacing for Termination and Prevention of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00123344
- Acronym / sponsor ID
- 15099
- Conditions
- Bradycardia, Atrial Fibrillation
- Keywords
- symptomatic bradycardia, paroxysmal atrial fibrillation, antitachycardia pacing therapies, prevention algorithms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Ontario
- Study start
- Dec 1999
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 22 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Life expectancy <3 years
- Unable to give informed consent
- Unable to come for followup
- Chronic AF
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AT501 pacemaker | Device | – |
Primary outcome
To determine the effects of antitachycardia pacing (ATP) therapies on prevention of atrial fibrillation recurrence over the long term
1 secondary outcome
To determine the effects of atrial pacing prevention algorithms on the time to recurrence of atrial fibrillation over the long term
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne M Gillis, MD principal investigator
University of Calgary, Professor of Medicine
D. George Wyse, MD, Ph.D study chair
University of Calgary, Professor of Medicine
John M Rothschild, MD study chair
University of Calgary, Professor of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AT501 pacemaker in people with Bradycardia and Atrial Fibrillation, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the effects of antitachycardia pacing (ATP) therapies on prevention of atrial fibrillation recurrence over the long term. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2008.