Continuous vital sign Monitoring with a Mobile Device in patients with high risk for Atrial fibrillation to identify and evaluate algorithms that detect A-fib episodes

• Conditions: I48.0; I47.0; Paroxysmal atrial fibrillation; Re-entry ventricular arrhythmia

• Registration Number: DRKS00014821
• Lead Sponsor: niversität Witten/Herdecke

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-05
• Study Completion: 2018-12-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age =18 years and able to understand design and objectives of the trial
• Patients with indication for ECG Holter monitoring, because of high risk for A-fib episodes (including at least 10 patients identified retrospectively to have a sinus rhythm)
• Willingness to continuously wear the additional device throughout the evaluation period
• Written informed consent and data safety agreement will be obtained before any trial-related activities

Exclusion Criteria

• Medical or mental conditions (e.g. dementia) impairing the ability to continuously wear the device throughout the evaluation period
• Wearing any active implants (e.g. pacemaker)
• Tattoos on the upper arm
• Presence of skin disease on the upper arm
• Allergic reaction to the device or its components (e.g. synthetic fabrics)
• Relevant coagulation disorder (e.g. known platelet count <30.000/µl)
• History of non-functional hemoglobin (Sickle-cell anemia, recent carbon monoxide intoxication)
• Mental incapacity or language barriers which preclude adequate understanding or cooperation, known or suspected not to comply with trial directives or not to be reliable or trustworthy, or subject who in the opinion of the investigator should not participate in the trial

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary:<br>• Part A: Identifying algorithms in the various parameters obtained which are highly indicative for A-fib.<br>• Part B: Head-to-head comparison of the CVSM algorithms to detect episodes of A-fib to the gold standard ECG Holter monitoring.

Secondary Outcome Measures

Name	Time	Method
Secondary:<br>• Identifying other arrhythmias (e.g. ventricular tachycardia) of ECG Holter monitoring also by CVSM data.<br>• Check oxygen saturations levels measured by CVSM while the software of the ECG Holter monitoring detects periods of sleep apnea.<br>• Compare interference rate in ECG Holter monitoring and CVSM.<br>• Feasibility of CVSM device usage under outpatient conditions (handling, data transfer, battery recharge).<br>• Quality of life associated with wearing a CVSM device.