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

Atrial Fibrillation Clinical Trial

— BAYathlon  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02875106
• Other study ID #: 18796
• Status: Completed
• Start date: November 8, 2017
• Est. completion date: May 8, 2019

Study information

• Verified date: May 2020
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: May 8, 2019
• Est. primary completion date: April 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• 12-point-ECG
routine recording will be 300 seconds
• Polar V800
routine recording will be 300 seconds
• 360° eMotion FAROS SET + Belt
routine recording will be 300 seconds
• Adidas Micoach smart run
routine recording will be 300 seconds
• TomTom Runner Cardio HRM
routine recording will be 300 seconds

Locations

Country	Name	City	State
Germany	Many Locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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

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