Sub-Clinical Atrial Fibrillation Biomarker Study (NCT02840201) | Clinical Trial Compass
CompletedNot Applicable
Sub-Clinical Atrial Fibrillation Biomarker Study
Canada321 participantsStarted 2017-06-26
Plain-language summary
This is a sub-study of the ARTESiA study registered as NCT01938248. This study is designed to validate biomarkers in subclinical atrial fibrillation and to determine if the prospective biomarker will be informative of the potential efficacy of treatment.
Who can participate
Age range
55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Permanent pacemaker or defibrillator (with or without resynchronization) or insertable cardiac monitor
* At least one episode of device-detected SCAF ≥ 6 minutes in duration but no single episode \> 24 hours in duration at any time prior to enrollment. Any atrial high rate episode with average \> 175 beats/min will be considered as SCAF. No distinction will be made between atrial fibrillation and atrial flutter. SCAF requires electrogram confirmation (at least one episode) unless ≥ 6 hours in duration
* Age ≥ 55 years
* Risk Factor(s) for Stroke:
Previous stroke, TIA or systemic arterial embolism OR Age at least 75 OR Age 65-74 with at least 2 other risk factors OR Age 55-64 with at least 3 other risk factors
Other risk factors are:
* Hypertension
* CHF
* Diabetes
* Vascular disease (i.e. CAD, PAD or Aortic Plaque)
* Female
* Must be from a participating Canadian recruitment centre
* Consent to participate in the ARTESiA parent study
Exclusion Criteria:
* Clinical atrial fibrillation documented by surface ECG (12 lead ECG, Telemetry, Holter) lasting ≥ 6 minutes, with or without clinical symptoms
* Mechanical valve prosthesis, recent (within past 6 months) deep vein thrombosis or pulmonary embolism or other condition requiring treatment with an anticoagulant
* Allergy to aspirin or apixaban
* Severe renal insufficiency (serum creatinine \> 2.5 mg/dL \[221 μmol/L\] or a calculated creatinine clearance \< 25 ml/min)
* Serious bleeding in the last 6 mo…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The burden of silent atrial fibrillation as recorded on implanted devices in patients
Timeframe: 3 years
Trial details
NCT IDNCT02840201
SponsorOttawa Heart Institute Research Corporation