Using Smart Phone Technology in Detecting the Presence of Atrial Fibrillation (iRead)

December 11, 2017 updated by: Khaldoun Tarakji, The Cleveland Clinic

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients admitted to the hospital for your atrial fibrillation or atrial flutter

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with Atrial Fibrillation
Patients with Atrial Fibrillation admitted to the hospital for drug loading with Dofetilide or Sotalol willing to record and transmit heart rhythm using AliveCor.
Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 month

Secondary Outcome Measures

Outcome 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.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Collaborators

AliveCor

Investigators

  • Principal Investigator: Khaldoun Tarakji, MD, The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

August 6, 2014

First Submitted That Met QC Criteria

August 11, 2014

First Posted (Estimate)

August 12, 2014

Study Record Updates

Last Update Posted (Actual)

December 13, 2017

Last Update Submitted That Met QC Criteria

December 11, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-612

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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