Mobile Phone Detection of Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— MODE-AF  

Official title:

Mobile Phone Detection of Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03274583
• Other study ID #: T02/005/17
• Status: Completed
• Start date: April 5, 2017
• Est. completion date: November 1, 2017

Study information

• Verified date: June 2019
• Source: University of Turku
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to evaluate the reliability of smartphone seismocardiographic detection of AF in comparison to the gold standard of continuous telemetry ECG recording.

Description:

In the this case-control study, 300 patients being treated in the wards of Heart Center and Department of Acute Internal Medicine of Turku University Hospital in Turku, Finland between April and September 2017 were included in the study. Patients were assigned to two groups according to the prevalent heart rhythm (sinus rhythm or atrial fibrillation). A smartphone equipped with an inbuilt accelerometer and a gyroscope was placed on the patient's chest to obtain a seismocardiographic recording. Simultaneous telemetry electrocardiography was obtained to assess the reliability of seismographic rhythm recordings. Results will be analyzed to describe the specificity and sensitivity of the method.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: November 1, 2017
• Est. primary completion date: October 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria for patients with FA:

• =18 years of age

• telemetry ECG available

• being treated in Turku University Hospital Heart Center / Acute internal medicine ward

• atrial fibrillation

Inclusion Criteria for patients with sinus rhythm:

• =18 years of age

• telemetry ECG available

• being treated in Turku University Hospital Heart Center / Acute internal medicine ward

• sinus rhythm

• gender and age matching pair in FA group

Exclusion Criteria:

• =18 years of age

• paced rhythm

• cardioversion during preceding 7 days

• informed consent not signed

Related Conditions & MeSH terms

• Arrhythmia
• Atrial Fibrillation

Intervention

Diagnostic Test:
• Smartphone seismographic recording
A short recording of heart rhythm using a smartphone.

Locations

Country	Name	City	State
Finland	Turku University Hospital	Turku	Länsi-Suomen Lääni

Sponsors (1)

Lead Sponsor	Collaborator
University of Turku

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of seismocardiography in diagnosing atrial fibrillation		2017-2018