Using Smart Phone Technology in Detecting the Presence of Atrial Fibrillation

Atrial Fibrillation Clinical Trial

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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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02214069
• Other study ID #: 14-612
• Status: Completed
• Phase: N/A
• First received: August 6, 2014
• Last updated: December 11, 2017
• Start date: August 2014
• Est. completion date: July 2017

Study information

• Verified date: December 2017
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Flutter

Intervention

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

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	AliveCor

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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