Overview

This trial is active, not recruiting.

Conditions atrial fibrillation, atrial flutter
Treatment record and transmit heart rhythm
Sponsor The Cleveland Clinic
Collaborator AliveCor
Start date August 2014
End date October 2016
Trial size 60 participants
Trial identifier NCT02214069, 14-612

Summary

The purpose of this study is to examine whether patients can use the AliveCor case to record their heart rhythm and to assess the accuracy of the software in detecting AF vs sinus rhythm

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients with Atrial Fibrillation admitted to the hospital for drug loading with Dofetilide or Sotalol willing to record and transmit heart rhythm using AliveCor.
record and transmit heart rhythm
The patient uses the AliveCor device to record and transmit heart rhythm two times a day. The patient, device software, and Electrophysiologist interpret the rhythm

Primary Outcomes

Measure
Examine the accuracy of the AliveCor software in detecting AF or sinus rhythm compared to the physician interpretation
time frame: 6 month

Secondary Outcomes

Measure
Assess the correlation between QT interval derived from the AliveCor device compared to standard 12 lead ECG, as assessed by the overreading electrophysiologists.
time frame: 6 months

Eligibility Criteria

All participants from 18 years up to 80 years old.

Inclusion Criteria: 1. Male or female between > 18 and < 80 years of age 2. Paroxysmal or persistent atrial fibrillation 3. Admitted for antiarrhythmic drug loading (Dofetilide or Sotalol) 4. Already has iPhone 4, 4S or 5 with data plan that accommodates the AliveCor case 5. Willing to use the Alive Cor case 6. Written informed consent Exclusion Criteria: 1. Unable or unwilling to use the Alive Cor case for their smart phone 2. Presence of a permanent pacemaker

Additional Information

Official title Assessing the Accuracy of an Atrial Fibrillation Detection Algorithm Using Novel Smart Phone Technology in Detecting the Presence of Atrial Fibrillation. iRead Study
Principal investigator Khaldoun Tarakji, MD
Description AliveCor is a new monitoring technology used with a smart phone which allows patients to record their rhythm. The study will compare AliveCor recordings and automated interpretation of the rhythm with the interpretation by an Electrophysiologist.
Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
Information provided to ClinicalTrials.gov by The Cleveland Clinic.