Device-detected Paroxysmal Atrial Fibrillation

Study Overview
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Brief Summary
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This study will use an automated blood pressure monitor (Microlife WatchBP03) with an inbuilt algorithm to detect atrial fibrillation (an irregular heart rhythm) in patients with an implanted pacemaker who have previously documented paroxysmal (intermittent) atrial fibrillation. This study will compare the Microlife device detected atrial fibrillation episodes to the pacemaker detected atrial fibrillation episodes.

Detailed Description
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The modified Microlife blood pressure monitor is able to detect atrial fibrillation (AF) with high sensitivity (95%) and specificity (86%) and has a positive predictive value of 68% and negative predictive value of 98% for single readings. In addition, the modified device was also able to accurately classify the majority of the anomalous non-AF rhythms, although the specificity was highly variable, dependent upon the rhythm. However sinus rhythm was detected with a specificity of 97%. However, we do not currently know if the device would demonstrate a similar sensitivity in detecting AF in patients with paroxysmal AF. Therefore, the present study will assess the sensitivity and specificity of the automated oscillometric device using a new AF algorithm among pacemaker patients with fast AF and atrial high-rate episodes and evaluate the effect of the specific rhythm abnormalities on the specificity for AF.

Official Title
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Validation of the Modified Microlife Blood Pressure Monitor in Patients With Paroxysmal Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Microlife WatchBP03 device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with an implanted pacemaker for sick sinus syndrome with previously documented AF with atrial high-rate episodes Exclusion Criteria: Any patient who's pacemaker has had previously documented atrial sensing or pacing problem issues Patients with permanent AF

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Microlife WatchBP03 device|Microlife WatchBP03 device which is an automated oscillometric device using a new algorithm to detect atrial fibrillation|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who are identified as having atrial fibrillation by both the pacemaker and the Microlife device (%) | True positive rate (sensitivity) | 24 hours | 
| Percentage of patients who are identified as not having atrial fibrillation by both the pacemaker and the Microlife device (%) | True negative rate (specificity) | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation; Pacemaker; Device-detected; Sensitivity; Specificity