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

Completed

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

• Registration Number: NCT02875106
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-18
• Study First Submitted QC: 2016-08-18
• Study First Posted: 2016-08-23
• Study Start: 2017-11-08
• Primary Completion: 2019-04-05
• Study Completion: 2019-05-08
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-07
• Last Update Posted: 2020-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Atrial Fibrillation Patients	12-point-ECG	Adult female and male patients with diagnosed atrial fibrillation
Atrial Fibrillation Patients	360° eMotion FAROS SET + Belt	Adult female and male patients with diagnosed atrial fibrillation
Atrial Fibrillation Patients	Adidas Micoach smart run	Adult female and male patients with diagnosed atrial fibrillation
Sinus Rhythm Patients	360° eMotion FAROS SET + Belt	Adult female and male patients with diagnosed sinus rhythm
Sinus Rhythm Patients	TomTom Runner Cardio HRM	Adult female and male patients with diagnosed sinus rhythm
Atrial Fibrillation Patients	Polar V800	Adult female and male patients with diagnosed atrial fibrillation
Atrial Fibrillation Patients	TomTom Runner Cardio HRM	Adult female and male patients with diagnosed atrial fibrillation
Sinus Rhythm Patients	Polar V800	Adult female and male patients with diagnosed sinus rhythm
Sinus Rhythm Patients	Adidas Micoach smart run	Adult female and male patients with diagnosed sinus rhythm
Sinus Rhythm Patients	12-point-ECG	Adult female and male patients with diagnosed sinus rhythm

Primary Outcome Measures

Name	Time	Method
The rate of correctly detected atrial fibrillation signals by CPDS in reference to ECG (sensitivity of CPDS).	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 Outcome Measures

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

Trial Locations

Locations (1)

Many Locations; 🇩🇪 Multiple Locations, Germany