Validation of an iPhone-based Event Recorder for Arrhythmia Detection
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Arrhythmia, Palpitations, Lightheadedness
- Sponsor
- University at Buffalo
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Validation of an iPhone-based Event Recorder for Arrhythmia Detection
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Deepika Narasimha
MD
University at Buffalo
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Validation of an iPhone-based Event Recorder for Arrhythmia Detection
Time Frame: one year
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.