Mobile Phone Detection of Atrial Fibrillation (MODE-AF)

June 28, 2019 updated by: Juhani Airaksinen, University of Turku
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.

Study Overview

Status

Completed

Detailed 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.

Study Type

Observational

Enrollment (Actual)

300

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

    • Länsi-Suomen Lääni
      • Turku, Länsi-Suomen Lääni, Finland, 20521
        • Turku University Hospital

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients treated in the wards of Heart Center and Acute Internal Medicine of Turku University Hospital, Turku Finland between April and September 2017.

Description

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

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
Study Group
Patients being treated in the wards of Heart Center and Acute Internal Medicine of Turku University Hospital, Turku Finland between April and September 2017 with atrial fibrillation as the prevalent rhythm.
A short recording of heart rhythm using a smartphone.
Control group
Patients being treated in the wards of Heart Center and Acute Internal Medicine of Turku University Hospital, Turku Finland between April and September 2017 with sinus rhythm as the prevalent rhythm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensitivity and specificity of seismocardiography in diagnosing atrial fibrillation
Time Frame: 2017-2018
2017-2018

Collaborators and Investigators

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

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)

April 5, 2017

Primary Completion (ACTUAL)

October 1, 2017

Study Completion (ACTUAL)

November 1, 2017

Study Registration Dates

First Submitted

September 4, 2017

First Submitted That Met QC Criteria

September 4, 2017

First Posted (ACTUAL)

September 7, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 1, 2019

Last Update Submitted That Met QC Criteria

June 28, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Atrial Fibrillation

Clinical Trials on Smartphone seismographic recording

3
Subscribe