NCT02875106

Brief Summary

The primary objective in this study is to identify commercial pulse detection systems (CPDS) parallel to electrocardiogram (ECG) recording within routine clinical setting, which are able to detect atrial fibrillation or sinus rhythm of screened patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
165

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2017

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

First Submitted

Initial submission to the registry

August 18, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 23, 2016

Completed
1.2 years until next milestone

Study Start

First participant enrolled

November 8, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2019

Completed
Last Updated

May 8, 2020

Status Verified

May 1, 2020

Enrollment Period

1.4 years

First QC Date

August 18, 2016

Last Update Submit

May 7, 2020

Conditions

Atrial Fibrillation

Keywords

Sinus rhythm

Outcome Measures

Primary Outcomes (1)

  • The rate of correctly detected atrial fibrillation signals by CPDS in reference to ECG (sensitivity of CPDS).

    This will be calculated as proportion of patients with atrial fibrillation diagnosed by CPDS record out of the total number of patients diagnosed with atrial fibrillation by ECG record (for patients with diagnosis for both recordings available).

    120 seconds

Secondary Outcomes (3)

  • The rate of correctly detected sinus rhythm signals by CPDS in reference to ECG (sensitivity of CPDS).

    120 seconds

  • The rate of correctly detected AF of the applied algorithm of the ECG-data in reference to the primary diagnosis of the investigator using the ECG-graph (sensitivity of algorithm).

    120 seconds

  • The rate of correctly detected atrial fibrillation signals by CPDS in reference to ECG (sensitivity of CPDS).

    60 seconds, 180 seconds, 240 seconds, 300 seconds

Study Arms (2)

Atrial Fibrillation Patients

Adult female and male patients with diagnosed atrial fibrillation

Device: 12-point-ECGDevice: Polar V800Device: 360° eMotion FAROS SET + BeltDevice: Adidas Micoach smart runDevice: TomTom Runner Cardio HRM

Sinus Rhythm Patients

Adult female and male patients with diagnosed sinus rhythm

Device: 12-point-ECGDevice: Polar V800Device: 360° eMotion FAROS SET + BeltDevice: Adidas Micoach smart runDevice: TomTom Runner Cardio HRM

Interventions

12-point-ECGDEVICE

routine recording will be 300 seconds

Atrial Fibrillation PatientsSinus Rhythm Patients
Polar V800DEVICE

routine recording will be 300 seconds

Atrial Fibrillation PatientsSinus Rhythm Patients
360° eMotion FAROS SET + BeltDEVICE

routine recording will be 300 seconds

Atrial Fibrillation PatientsSinus Rhythm Patients
Adidas Micoach smart runDEVICE

routine recording will be 300 seconds

Atrial Fibrillation PatientsSinus Rhythm Patients
TomTom Runner Cardio HRMDEVICE

routine recording will be 300 seconds

Atrial Fibrillation PatientsSinus Rhythm Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients for whom the decision to record an ECG was made as per investigator's routine treatment practice

You may qualify if:

  • Adult female and male patients for whom the decision to record an ECG was made as per investigator's routine treatment practice
  • Patient able and willing to provide signed informed consent

You may not qualify if:

  • Patients with any comorbidities or abnormalities of heart function or rhythm, which might, in the opinion of the investigator, interfere with the evaluation of study data
  • Patients participating in an investigational program with interventions outside of routine clinical practice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Many Locations

Multiple Locations, Germany

Location

Related Publications (1)

  • Muller C, Hengstmann U, Fuchs M, Kirchner M, Kleinjung F, Mathis H, Martin S, Blase I, Perings S. Distinguishing atrial fibrillation from sinus rhythm using commercial pulse detection systems: The non-interventional BAYathlon study. Digit Health. 2021 May 22;7:20552076211019620. doi: 10.1177/20552076211019620. eCollection 2021 Jan-Dec.

    PMID: 34104466DERIVED

Related Links

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2016

First Posted

August 23, 2016

Study Start

November 8, 2017

Primary Completion

April 5, 2019

Study Completion

May 8, 2019

Last Updated

May 8, 2020

Record last verified: 2020-05

Locations

DE(1)