Validation of an iPhone-based Event Recorder for Arrhythmia Detection

Not Applicable

Completed

• Conditions: Arrhythmia, Palpitations, Lightheadedness

• Registration Number: NCT02005172
• Lead Sponsor: University at Buffalo

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:

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-12-03
• Study First Submitted QC: 2013-12-03
• Study First Posted: 2013-12-09
• Primary Completion: 2016-03
• Study Completion: 2016-05
• Results First Submitted: 2020-09-28
• Results First Submitted QC: 2022-05-17
• Results First Posted: 2022-06-13
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-29
• Last Update Posted: 2023-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Validation of an iPhone-based Event Recorder for Arrhythmia Detection	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.

Trial Locations

Locations (1)

Dent Towers; 🇺🇸 Buffalo, New York, United States