A Digital Non-interventional Atrial Fibrillation (AF) Screening Study With Commercial Pulse Detection Systems (BAYathlon)

BAYathlon - a Digital Non-interventional AF Screening Study to Identify Commercial Pulse Detection Systems (CPDS) Detecting AF and Sinus Rhythm Parallel to ECG Recording Within Routine Clinical Setting

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: 12-point-ECG; Device: Polar V800; Device: 360° eMotion FAROS SET + Belt; Device: Adidas Micoach smart run; Device: TomTom Runner Cardio HRM

• Study Type: Observational
• Enrollment (Actual): 165

Contacts and Locations

Study Locations

• Germany
  • Multiple Locations, Germany
    • Many locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Atrial Fibrillation Patients; Adult female and male patients with diagnosed atrial fibrillation	Device: 12-point-ECG; routine recording will be 300 seconds; Device: Polar V800; routine recording will be 300 seconds; Device: 360° eMotion FAROS SET + Belt; routine recording will be 300 seconds; Device: Adidas Micoach smart run; routine recording will be 300 seconds; Device: TomTom Runner Cardio HRM; routine recording will be 300 seconds
Sinus Rhythm Patients; Adult female and male patients with diagnosed sinus rhythm	Device: 12-point-ECG; routine recording will be 300 seconds; Device: Polar V800; routine recording will be 300 seconds; Device: 360° eMotion FAROS SET + Belt; routine recording will be 300 seconds; Device: Adidas Micoach smart run; routine recording will be 300 seconds; Device: TomTom Runner Cardio HRM; routine recording will be 300 seconds

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of correctly detected sinus rhythm signals by CPDS in reference to ECG (sensitivity of CPDS).	This will be calculated as proportion of patients with sinus rhythm diagnosed by CPDS record out of the total number of patients diagnosed with sinus rhythm by ECG record (for patients with diagnosis for both recordings available).	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).	This will be calculated as proportion of AF patients detected by the applied algorithm compared with proportion of AF patients diagnosed by the investigator, both based on ECG records.	120 seconds
The rate of correctly detected atrial fibrillation signals by CPDS in reference to ECG (sensitivity of CPDS).	This will be a sensitivity analysis of derived sensitivities of CPDS in different time frames, calculated as proportion of patients with sinus rhythm diagnosed by CPDS record out of the total number of patients diagnosed with sinus rhythm by ECG record (for patients with diagnosis for both recordings available).	60 seconds, 180 seconds, 240 seconds, 300 seconds

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

General Publications

• Müller C, Hengstmann U, Fuchs M, Kirchner M, Kleinjung F, Mathis H, Martin S, Bläse 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2017
• Primary Completion (Actual): April 5, 2019
• Study Completion (Actual): May 8, 2019

Study Registration Dates

• First Submitted: August 18, 2016
• First Submitted That Met QC Criteria: August 18, 2016
• First Posted (Estimate): August 23, 2016

Study Record Updates

• Last Update Posted (Actual): May 8, 2020
• Last Update Submitted That Met QC Criteria: May 7, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Sinus rhythm
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 18796

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No