Validation of an iPhone-based Event Recorder for Arrhythmia Detection
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology, Neurology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | November 2013 |
| End Date: | May 2016 |
| Contact: | Deepika Narasimha, MD |
| Email: | deepikan@buffalo.edu |
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.
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.
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