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Completed

NCT Number: NCT02214069

Using Smart Phone Technology in Detecting the Presence of Atrial Fibrillation

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

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Atrial Flutter Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female between > 18 and < 80 years of age
  • Paroxysmal or persistent atrial fibrillation
  • Admitted for antiarrhythmic drug loading (Dofetilide or Sotalol)
  • Already has iPhone 4, 4S or 5 with data plan that accommodates the AliveCor case
  • Willing to use the Alive Cor case
  • Written informed consent

Exclusion criteria

  • Unable or unwilling to use the Alive Cor case for their smart phone
  • Presence of a permanent pacemaker

Treatment and study plan

Record and transmit heart rhythm

Device

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

  1. Examine the accuracy of the AliveCor software in detecting AF or sinus rhythm compared to the physician interpretation

    Time frame: 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • AliveCor

Registry information

Official study title

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

Acronym: iRead

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Aug 12, 2014
Registry last updated
Dec 13, 2017

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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