N/A N=33 Diagnostic

Validation of an iPhone-based Event Recorder for Arrhythmia Detection

Arrhythmia, Palpitations, Lightheadedness

Bottom Line

View on ClinicalTrials.gov: NCT02005172 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2022

Primary outcome: Primary: Validation of an iPhone-based Event Recorder for Arrhythmia Detection — 14; 12; 8; 8 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Alivecor monitor and 14 day event monitor (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University at Buffalo
Primary completion: Mar 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Validation of an iPhone-based Event Recorder for Arrhythmia Detection	14; 12; 8; 8; 5; 2	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02005172). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.