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

Bayer165 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

165

Conditions

Atrial Fibrillation

Interventions

12-point-ECGDEVICE

routine recording will be 300 seconds

Polar V800DEVICE

routine recording will be 300 seconds

360° eMotion FAROS SET + BeltDEVICE

routine recording will be 300 seconds

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Many Locations

Multiple Locations, Germany

Outcomes

Primary Outcomes

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).

Time frame: 120 seconds

Secondary Outcomes

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).

Time 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.

Time 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).

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

Data from ClinicalTrials.gov

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