NCT03274583

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 5, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 7, 2017

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

July 1, 2019

Status Verified

June 1, 2019

Enrollment Period

6 months

First QC Date

September 4, 2017

Last Update Submit

June 28, 2019

Conditions

Atrial FibrillationArrhythmia

Keywords

atrial fibrillationsmartphonedetection

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and specificity of seismocardiography in diagnosing atrial fibrillation

    2017-2018

Study Arms (2)

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.

Diagnostic Test: Smartphone seismographic recording

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.

Interventions

Smartphone seismographic recordingDIAGNOSTIC_TEST

A short recording of heart rhythm using a smartphone.

Study Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • ≥18 years of age
  • telemetry ECG available
  • being treated in Turku University Hospital Heart Center / Acute internal medicine ward
  • atrial fibrillation
  • ≥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

You may not qualify if:

  • ≤18 years of age
  • paced rhythm
  • cardioversion during preceding 7 days
  • informed consent not signed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Hospital

Turku, Länsi-Suomen Lääni, 20521, Finland

Location

MeSH Terms

Conditions

Atrial FibrillationArrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 4, 2017

First Posted

September 7, 2017

Study Start

April 5, 2017

Primary Completion

October 1, 2017

Study Completion

November 1, 2017

Last Updated

July 1, 2019

Record last verified: 2019-06

Locations

FI(1)