About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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
Trial population
Investigators will recruit patients with a permanent defibrillator or pacemaker who have an upcoming appointment at the Device Clinic.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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
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
Secondary outcomes
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
Sponsors and contacts
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Ottawa Heart Institute Research Corporation
Lead sponsor
Genome Canada
Collaborator