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Clinical Trials/DRKS00014821
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.

Registry
who.int
Start Date
June 5, 2018
End Date
December 20, 2018
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
niversität Witten/Herdecke

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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