Prevalence of Sub-Clinical Atrial Fibrillation in Elderly Patients With Hypertension, Detected Using an External Loop Recorder

Study Overview
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Brief Summary
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The ASSERT-III study aims to determine the incidence of sub-clinical (silent) atrial fibrillation (AF) among elderly patients with hypertension and at least one other risk factor for AF. This will be accomplished by monitoring with a wireless external loop monitor for 30 to 60 days.

Official Title
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Prevalence of Sub-Clinical Atrial Fibrillation in Elderly Patients With Hypertension, Detected Using an External Loop Recorder Using Automatic Algorithms for AF Detection: A Pilot Study (ASSERT-III)

Conditions
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Elderly, Hypertension, Risk Factors for Atrial Fibrillation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients will be eligible for inclusion if they meet all of the following: Age ≥ 80 years History of hypertension OR a blood pressure of ≥ 140/90 mmHg Attending a primary care clinic, OR ambulatory resident of a chronic care facility At least one of the following additional risk factors for developing AF: Diabetes Body mass index ≥ 30 History of smoking Documented Obstructive sleep apnea Cardiovascular disease Heart Failure Left ventricular hypertrophy (on ECG or echocardiography) Provide written informed consent Exclusion Criteria: ECG documented history of AF or atrial flutter, with an episode duration ≥ 6 minutes Existing implanted pacemaker or defibrillator Patients considered by the investigator to be unsuitable for study follow-up because the patient: is unreliable concerning the requirements for follow-up during the study and/or compliance with the use of the external loop recorder has a life expectancy less that the expected study duration due to concomitant disease has a condition which in the opinion of the investigator, would not allow current chronic treatment with anticoagultion -

Ages Eligible for Study
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Minimum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurance of atrial fibrillation episode | Detection rate of sub-clinical atrial fibrillation episodes, at least 6 minutes in duration | within 30 - 60 days of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability and feasibility of long term monitoring in elderly patients | The tolerability of long-term monitoring in elderly patients and the ability of these patients to manually transmit data to the cardiac analyses centre. | 30 - 60 days of follow-up | 
| Proportion of patients eligible to receive anticoagulation |  | 30 - 60 days of follow-up | 
| AF Burden | An estimate of the burden of atrial arrhythmias (from device logs) in patients with AF. | 30 - 60 days of follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, hypertension, risk factors, primary care, elderly