DRKS00014821
Completed
Not Applicable
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 - CoMMoD-A-fib
niversität Witten/Herdecke0 sites100 target enrollmentJune 5, 2018
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- I48.0
- Sponsor
- niversität Witten/Herdecke
- Enrollment
- 100
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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