Atrial FibrillationNCT02808260
Predicting Development of SCAF in Device Patients
An observational study of Atrial Fibrillation, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial summary
Atrial fibrillation (AF) often starts with short episodes of rapid irregular heartbeats that are only detected by implanted pacemakers or defibrillators. Usually people don't know that they have these episodes. Over time, these episodes can happen more often and last for longer periods. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 500 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2022to Sep 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Investigators will recruit patients with a permanent defibrillator or pacemaker who have an upcoming appointment at the Device Clinic.
Who may be able to join
- Dual chamber permanent pacemaker or defibrillator implanted within previous 10 years
Who cannot join
- Clinical atrial fibrillation documented by surface ECG (12 lead ECG, Telemetry, Holter)
- Participants considered by the investigator to be unsuitable for the study for the following reason: life expectancy less than 2 years due to concomitant disease
- Participants who are pregnant or breast-feeding
- Congenital heart disease
- Inherited arrhythmia syndrome, i.e. Brugada, long QT interval
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Tammy Knight, 613-696-7000 ext. 19080, tknight@ottawaheart.ca
About this study
Official title: Predicting Development of Sub-Clinical Atrial Fibrillation in Device Patients
Atrial fibrillation (AF) often starts with short episodes of rapid irregular heartbeats that are only detected by implanted pacemakers or defibrillators. Usually people don't know that they have these episodes. Over time, these episodes can happen more often and last for longer periods. In some people, the heart eventually remains permanently in a fast irregular rhythm, known as atrial fibrillation. This condition can lead to strokes and blood clots. If physicians could detect atrial fibrillation at a very early stage they could treat people early and possibly prevent the condition from becoming permanent. People with implanted devices allow a unique opportunity to constantly monitor the heart rhythm so investigators can detect any irregularities immediately.
Investigators don't know which people are at risk of developing short episodes of fast irregular heartbeats that can lead to atrial fibrillation. The purpose of this study is to find out if there are proteins or chemical changes in the blood that can predict the risk of developing atrial fibrillation. These chemical changes, also known as biomarkers, may also be able to give investigators other clues about atrial fibrillation.
Read the detailed description
Atrial fibrillation (AF) is considered to be a progressive condition that starts with episodes of paroxysmal AF (short runs of AF), progresses to persistent AF (can be reverted to normal rhythm) and eventually to permanent AF. More than 25% of people with paroxysmal AF will go on to develop persistent or chronic atrial fibrillation. The progression rate is around 5% per annum. AF can result in devastating outcomes such as stroke/TIA and systemic embolic events. In people with implanted devices such as ICDs, investigators can detect non-symptomatic rapid atrial arrhythmia, known as subclinical atrial fibrillation (SCAF), before it becomes symptomatic. In the ASSERT trial, SCAF was detected in 10% of patients with newly implanted devices within the first 3 months. Of these, nearly 16% developed clinical atrial fibrillation within 2.5 years vs 3% in those who did not exhibit SCAF within the first 3 months. During the follow up period, a further 24.5% of patients developed SCAF. People with SCAF also had a higher risk of stroke and systemic embolism.
Earlier diagnosis and treatment of AF may lead to better prevention and outcomes. The availability of serum based biomarkers that can predict the early onset of atrial fibrillation, may help in the identification of patients at risk for developing AF early. This would also allow the identification of the patient population most suitable for the evaluation of possible future intervention strategies to prevent the onset of atrial fibrillation, and alter its natural history and complications.
In this study investigators will study patients that have a permanent pacemaker or defibrillator implanted. These devices continuously monitor the patient's heart rhythm, detecting any irregularities. Patients with these devices are followed up in outpatient clinics on a regular basis. The information from the devices is downloaded at each follow up visit and analyzed by staff in the clinic.
Investigators will recruit patients for this study after the device was implanted. After obtaining consent, investigators will collect a blood sample for measuring biomarkers. They will interview the participant in regards to previous health history, smoking, alcohol consumption, family history and current medications. Participants' medical records will be reviewed annually for the next 10 years, to monitor for any irregular heart rhythms, hospitalizations and death.
- Conditions
- Atrial Fibrillation
- Keywords
- sub-clinical atrial fibrillation, biomarkers, implanted pacemaker or defibrillator
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
The development of new Sub-Clinical Atrial Fibrillation as recorded on implanted devices
Participants will be monitored by clinical follow up for a year and then medical record reviews for an additional 10 years
Measured: 11 years
Sub-clinical Atrial Fibrillation as predicted by biomarkers
Biomarkers will be measured at baseline and after 1 year to see if biomarkers can predict which people will develop sub-clinical atrial fibrillation during the 11 year follow up period
Measured: 11 years
Secondary outcomes (1)
The development of clinical atrial fibrillation, including persistent atrial fibrillation.
The investigators will monitor participants to see how many develop persistent atrial fibrillation within 11 years of device implant
Measured: 11 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study start1 Sep 2022
- Primary completionSep 2034 (estimated)
- Study completionSep 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Genome Canada
- Responsible party
- Sponsor
- Investigators
- Pablo Nery, MD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808260
- Sponsor's protocol ID
- 20160338
- Status last verified
- Jul 2026
- First submitted
- 13 Jun 2016
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Development of Sub-Clinical Atrial Fibrillation in Device Patients
- ClinicalTrials.gov ID
- NCT02808260
- Acronym / sponsor ID
- 20160338
- Conditions
- Atrial Fibrillation
- Keywords
- sub-clinical atrial fibrillation, biomarkers, implanted pacemaker or defibrillator
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Collaborators
- Genome Canada
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- Sep 2034 (estimated)
- Study completion
- Sep 2034 (estimated)
- First posted
- 21 Jun 2016 (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) often starts with short episodes of rapid irregular heartbeats that are only detected by implanted pacemakers or defibrillators. Usually people don't know that they have these episodes. Over time, these episodes can happen more often and last for longer periods. In some people, the heart eventually remains permanently in a fast irregular rhythm, known as atrial fibrillation. This condition can lead to strokes and blood clots. If physicians could detect atrial fibrillation at a very early stage they could treat people early and possibly prevent the condition from becoming permanent. People with implanted devices allow a unique opportunity to constantly monitor the heart rhythm so investigators can detect any irregularities immediately.
Investigators don't know which people are at risk of developing short episodes of fast irregular heartbeats that can lead to atrial fibrillation. The purpose of this study is to find out if there are proteins or chemical changes in the blood that can predict the risk of developing atrial fibrillation. These chemical changes, also known as biomarkers, may also be able to give investigators other clues about atrial fibrillation.
Detailed description
Atrial fibrillation (AF) is considered to be a progressive condition that starts with episodes of paroxysmal AF (short runs of AF), progresses to persistent AF (can be reverted to normal rhythm) and eventually to permanent AF. More than 25% of people with paroxysmal AF will go on to develop persistent or chronic atrial fibrillation. The progression rate is around 5% per annum. AF can result in devastating outcomes such as stroke/TIA and systemic embolic events. In people with implanted devices such as ICDs, investigators can detect non-symptomatic rapid atrial arrhythmia, known as subclinical atrial fibrillation (SCAF), before it becomes symptomatic. In the ASSERT trial, SCAF was detected in 10% of patients with newly implanted devices within the first 3 months. Of these, nearly 16% developed clinical atrial fibrillation within 2.5 years vs 3% in those who did not exhibit SCAF within the first 3 months. During the follow up period, a further 24.5% of patients developed SCAF. People with SCAF also had a higher risk of stroke and systemic embolism.
Earlier diagnosis and treatment of AF may lead to better prevention and outcomes. The availability of serum based biomarkers that can predict the early onset of atrial fibrillation, may help in the identification of patients at risk for developing AF early. This would also allow the identification of the patient population most suitable for the evaluation of possible future intervention strategies to prevent the onset of atrial fibrillation, and alter its natural history and complications.
In this study investigators will study patients that have a permanent pacemaker or defibrillator implanted. These devices continuously monitor the patient's heart rhythm, detecting any irregularities. Patients with these devices are followed up in outpatient clinics on a regular basis. The information from the devices is downloaded at each follow up visit and analyzed by staff in the clinic.
Investigators will recruit patients for this study after the device was implanted. After obtaining consent, investigators will collect a blood sample for measuring biomarkers. They will interview the participant in regards to previous health history, smoking, alcohol consumption, family history and current medications. Participants' medical records will be reviewed annually for the next 10 years, to monitor for any irregular heart rhythms, hospitalizations and death.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Investigators will recruit patients with a permanent defibrillator or pacemaker who have an upcoming appointment at the Device Clinic.
Key inclusion criteria (1 listed)
- Dual chamber permanent pacemaker or defibrillator implanted within previous 10 years
Key exclusion criteria (5 listed)
- Clinical atrial fibrillation documented by surface ECG (12 lead ECG, Telemetry, Holter)
- Participants considered by the investigator to be unsuitable for the study for the following reason: life expectancy less than 2 years due to concomitant disease
- Participants who are pregnant or breast-feeding
- Congenital heart disease
- Inherited arrhythmia syndrome, i.e. Brugada, long QT interval
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The development of new Sub-Clinical Atrial Fibrillation as recorded on implanted devices
Time frame: 11 years
Participants will be monitored by clinical follow up for a year and then medical record reviews for an additional 10 years
Sub-clinical Atrial Fibrillation as predicted by biomarkers
Time frame: 11 years
Biomarkers will be measured at baseline and after 1 year to see if biomarkers can predict which people will develop sub-clinical atrial fibrillation during the 11 year follow up period
1 secondary outcome
The development of clinical atrial fibrillation, including persistent atrial fibrillation.
Time frame: 11 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Pablo Nery, MD principal investigator
Ottawa Heart Institute Research Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Ottawa Heart Institute Research Corporation 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 1 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 13 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tammy Knight (613-696-7000 ext. 19080, tknight@ottawaheart.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The development of new Sub-Clinical Atrial Fibrillation as recorded on implanted devices (time frame: 11 years). The study lists 2 primary outcomes in all. 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 13 Jul 2026.