Using Smart Phone Technology in Detecting the Presence of Atrial Fibrillation

NCT02214069 | Completed FDA Device

• 1 other identifier: 14-612
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Atrial Fibrillation; Atrial Flutter

Outcome Measures

Primary Outcomes (1)

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

  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 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.

  6 months

Study Arms (1)

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

Interventions

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

Patients with Atrial Fibrillation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• AliveCor: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• William AD, Kanbour M, Callahan T, Bhargava M, Varma N, Rickard J, Saliba W, Wolski K, Hussein A, Lindsay BD, Wazni OM, Tarakji KG. Assessing the accuracy of an automated atrial fibrillation detection algorithm using smartphone technology: The iREAD Study. Heart Rhythm. 2018 Oct;15(10):1561-1565. doi: 10.1016/j.hrthm.2018.06.037. Epub 2018 Aug 22.

  PMID: 30143448 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter

Interventions

Records

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Khaldoun Tarakji, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff

Study Record Dates

• First Submitted: August 6, 2014
• First Posted: August 12, 2014
• Study Start: August 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: July 1, 2017
• Last Updated: December 13, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)