check_circleStudy Completed

Atrial fibrillation

Bayer Identifier:

18796

ClinicalTrials.gov Identifier:

NCT02875106

EudraCT Number:

Not Available

EU CT Number:

Not Available
A digital non-interventional atrial fibrillation (AF) screening study with commercial pulse detection systems

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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

  • - 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 summary

Enrollment Goal
165
Trial Dates
November 2017 - May 2019
Phase
N/A
Could I Receive a placebo
No
Products
Unspecified
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many LocationsMany Locations, Germany

Primary Outcome

  • 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).
    date_rangeTime Frame:
    120 seconds
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • 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).
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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).
    date_rangeTime Frame:
    60 seconds, 180 seconds, 240 seconds, 300 seconds

Trial design

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
Trial Type
Observational
Intervention Type
Device
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information