Identifying early signs of atrial fibrillation in patients with heart devices
Predicting Development of Sub-Clinical Atrial Fibrillation in Device Patients
This study is trying to find early signs of irregular heartbeats in people with pacemakers or defibrillators to see if certain markers can help predict who might develop atrial fibrillation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ottawa Heart Institute Research Corporation Academic / other |
| Locations | 1 site (Ottawa, Ontario) |
| Trial ID | NCT02808260 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify biomarkers that can predict the development of subclinical atrial fibrillation (SCAF) in patients with implanted pacemakers or defibrillators. By monitoring heart rhythms continuously, the study seeks to detect early episodes of rapid irregular heartbeats that may lead to atrial fibrillation. The research will analyze chemical changes and proteins in patients to determine who is at risk of developing this condition. Early detection could enable timely intervention to prevent the progression to permanent atrial fibrillation, which is associated with serious complications like strokes.
Who should consider this trial
Good fit: Ideal candidates are individuals with a dual chamber permanent pacemaker or defibrillator implanted within the last 10 years.
Not a fit: Patients who have documented clinical atrial fibrillation or other significant health issues that limit their life expectancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier diagnosis and treatment of atrial fibrillation, potentially reducing the risk of strokes and other serious complications.
How similar studies have performed: Previous studies, such as the ASSERT trial, have shown success in detecting subclinical atrial fibrillation, indicating that this approach has potential for further exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: • Dual chamber permanent pacemaker or defibrillator implanted within previous 10 years Exclusion Criteria: * 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
Where this trial is running
Ottawa, Ontario
- University of Ottawa Heart Institute — Ottawa, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Pablo Nery, MD — Ottawa Heart Institute Research Corporation
- Study coordinator: Tammy Knight
- Email: tknight@ottawaheart.ca
- Phone: 613-696-7000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.