Using Smart Phone Technology in Detecting the Presence of Atrial Fibrillation

Completed

• Conditions: Atrial Flutter; Atrial Fibrillation
• Interventions: Device: Record and transmit heart rhythm

• Registration Number: NCT02214069
• Lead Sponsor: The Cleveland Clinic

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.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-06
• Study First Submitted QC: 2014-08-11
• Study First Posted: 2014-08-12
• Primary Completion: 2016-10
• Study Completion: 2017-07
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-11
• Last Update Posted: 2017-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Atrial Fibrillation	Record and transmit heart rhythm	Patients with Atrial Fibrillation admitted to the hospital for drug loading with Dofetilide or Sotalol willing to record and transmit heart rhythm using AliveCor.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States