I48.0 I47.0
Conditions
Interventions
Group 1: Each included patient receives the CVSM device in addition to the holter monitor (indication must be given) and should wear it for the duration of holter monitoring.
Sponsors
Universität Witten/Herdecke
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary: • Part A: Identifying algorithms in the various parameters obtained which are highly indicative for A-fib. • Part B: Head-to-head comparison of the CVSM algorithms to detect episodes of A-fib to the gold standard ECG Holter monitoring. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary: • Identifying other arrhythmias (e.g. ventricular tachycardia) of ECG Holter monitoring also by CVSM data. • Check oxygen saturations levels measured by CVSM while the software of the ECG Holter monitoring detects periods of sleep apnea. • Compare interference rate in ECG Holter monitoring and CVSM. • Feasibility of CVSM device usage under outpatient conditions (handling, data transfer, battery recharge). • Quality of life associated with wearing a CVSM device. | — |
Countries
Germany
Contacts
Public ContactMalte Jacobsen
Helios Universitätsklinikum Wuppertal
Outcome results
None listed