Validation of an iPhone-based Event Recorder for Arrhythmia Detection

Study Overview
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Brief Summary
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In this study, we will evaluate the diagnostic yield of the new AliveCor device versus a 14 day event monitor with the use of both devices simultaneously. We will also examine by means of a questionnaire the compliance, ease of use and patient satisfaction for each device. Hypothesis: The AliveCor monitor will be non-inferior to the 14 day event monitor with respect to diagnosis of the arrhythmia responsible for a patient's symptoms. The AliveCor monitor will have better compliance and acceptability compared to the 14 day event monitor, and thus there will be a greater number of days with recordings from the AliveCor monitor.

Official Title
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Validation of an iPhone-based Event Recorder for Arrhythmia Detection

Conditions
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Arrhythmia, Palpitations, Lightheadedness

Intervention / Treatment
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* Device: Alivecor monitor and 14 day event monitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients >18 years of age with symptoms such as palpitations or pre-syncope suggestive of arrhythmias (usually occurring less frequently than once a day) with prior non-diagnostic ECGs and/or Holter monitoring. Patients who own an iPhone 4, 4S or 5 device and demonstrate the capability of recording and uploading a test ECG recording at the office visit. Exclusion Criteria: Patients <18 years of age. Patients with a myocardial infarction (MI) within the last three months, and/or known history of sustained VT/VF. Patients with NYHA class IV heart failure. Patients with unstable angina. Patients with syncope as the presenting symptom. Patients unable to or unwilling to use the device.

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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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Alivecor device and event monitor<br>Both the Alivecor device (experimental) and the standard of care (event monitor) will be provided to all patients for the duration of the study | Device: Alivecor monitor and 14 day event monitor<br>* Alivecor monitor and 14 day event monitor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of an iPhone-based Event Recorder for Arrhythmia Detection | For the primary endpoint, equivalence testing using the two one-sided test (TOST) procedure was used to compare the proportion of unpaired days in which a diagnostic recording was made with each device during the monitoring period. A difference of less than 10% between the devices on the rate of detection of arrhythmias was taken to indicate equivalence. | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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arrhythmia, palpitations, lightheadedness