NCT02005172

Validation of an iPhone-based Event Recorder for Arrhythmia Detection

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: University at Buffalo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arrhythmia, Palpitations, Lightheadedness

Interventions

Type	Name	Description
DEVICE	Alivecor monitor and 14 day event monitor	Alivecor monitor and 14 day event monitor

Timeline

• Start date: 2013-11-01
• Primary completion: 2016-03-01
• Completion: 2016-05-01
• First posted: 2013-12-09
• Last updated: 2023-05-25
• Results posted: 2022-06-13

Locations

1 site across 1 country: United States