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 range55 Years
SexALL
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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…
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