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

Bayer

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Device: TomTom Runner Cardio HRM; Device: 12-point-ECG; Device: Polar V800; Device: 360° eMotion FAROS SET + Belt; Device: Adidas Micoach smart run

Study type: Observational

Funder types: Industry

Identifiers

NCT02875106

18796

Details and patient eligibility

About

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.

Enrollment: 165 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

165 participants in 2 patient groups

Atrial Fibrillation Patients

Description:

Adult female and male patients with diagnosed atrial fibrillation

Treatment:

Device: TomTom Runner Cardio HRM

Device: 360° eMotion FAROS SET + Belt

Device: Polar V800

Device: Adidas Micoach smart run

Device: 12-point-ECG

Sinus Rhythm Patients

Description:

Adult female and male patients with diagnosed sinus rhythm

Treatment:

Device: TomTom Runner Cardio HRM

Device: 360° eMotion FAROS SET + Belt

Device: Polar V800

Device: Adidas Micoach smart run

Device: 12-point-ECG