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Completed

NCT Number: NCT02875106

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations

Multiple Locations, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

12-point-ECG

Device

routine recording will be 300 seconds

Polar V800

Device

routine recording will be 300 seconds

360° eMotion FAROS SET + Belt

Device

routine recording will be 300 seconds

Adidas Micoach smart run

Device

routine recording will be 300 seconds

TomTom Runner Cardio HRM

Device

routine recording will be 300 seconds

Primary outcomes

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

    Time frame: 120 seconds

    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).

Secondary outcomes

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

    Time frame: 120 seconds

    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).

  2. 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).

    Time frame: 120 seconds

    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.

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

    Time frame: 60 seconds, 180 seconds, 240 seconds, 300 seconds

    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).

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: BAYathlon

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 23, 2016
Registry last updated
May 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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