Validation of an iPhone-based Event Recorder for Arrhythmia Detection

Validation of an iPhone-based Event Recorder for Arrhythmia Detection

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:

1. 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.
2. 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.

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:

1. Patients <18 years of age.
2. Patients with a myocardial infarction (MI) within the last three months, and/or known history of sustained VT/VF.
3. Patients with NYHA class IV heart failure.
4. Patients with unstable angina.
5. Patients with syncope as the presenting symptom.
6. Patients unable to or unwilling to use the device.