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.

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Key information

Conditions

Arrhythmia, Palpitations, Lightheadedness Arrhythmias, Cardiac Cardiovascular Diseases Dizziness Heart Diseases Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dent Towers

Buffalo, New York, 14226, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Alivecor monitor and 14 day event monitor

Device

Alivecor monitor and 14 day event monitor

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.

Sponsors and collaborators

Lead sponsor

University at Buffalo

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2016
First posted: Dec 9, 2013
Registry last updated: May 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed