Using Smart Phone Technology in Detecting the Presence of Atrial Fibrillation

Assessing the Accuracy of an Atrial Fibrillation Detection Algorithm Using Novel Smart Phone Technology in Detecting the Presence of Atrial Fibrillation. iRead Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02214069

Acronym

iRead

Enrollment

Registered

2014-08-12

Start date

2014-08-31

Completion date

2017-07-31

Last updated

2017-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Atrial Flutter

Brief 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

Detailed 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.

Interventions

DEVICERecord 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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Examine the accuracy of the AliveCor software in detecting AF or sinus rhythm compared to the physician interpretation	6 month	Both the software nd overreading electrophysiologist come to the same conclusion regarding the rhythm of the ECG and Alivecor reading. Both determining that the tracing is either normal sinus rhythm or atrial fibrillation.

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026