Trial document




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  DRKS00014821

Trial Description

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Title

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

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Trial Acronym

CoMMoD-A-fib

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URL of the Trial

[---]*

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Brief Summary in Lay Language

CoMMoD-A-fib study focusses on atrial fibrillation, a cardiac arrhythmia, a common cause of strokes and transient ischemic attacks (TIA). The diagnosis of this Cardiac arrhythmia by evaluation relies on ECG recordings. Due to the irregular occurrence of atrial fibrillation a long-term ECG must be performed by default. In a considerable number of cases these surveillance techniques fail to detect atrial fibrillation episodes. CoMMoD-A-fib uses new (approved) technological systems to perform a non-invasive and continuous monitoring of vital signs (heart rate, oxygen saturation, skin temperature, skin perfusion and movement) to detect the cardiac arrhythmia.

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Brief Summary in Scientific Language

Non-invasive wire-less continuous tracking of vital signs (CVSM) is a technology that became available recently, it allows a reliable collection of clinically relevant data and offers the potential of telemonitoring of such data. The basic technologies employed is photo plethysmography, accelerometry and temperature sensors. However, the challenge is to analyze the volume of data which are provided by CVSM for clinically relevant signals / information. There is a need for novel algorithms that help to detect automatically critical clinical conditions with a sufficient sensitivity and specificity. Preliminary evaluations using CVSM confirmed that for example automatic detection of Atrial fibrillation (A-fib) is possible by this approach; however, sensitivity and specificity was not sufficient. The device which will be used in the CoMMoD-A-fib Study allows continuous monitoring of a variety of parameters and promises a low interference rate, which is assumed to result in a good sensitivity and specificity. Currently an ECG recording represents the gold standard for diagnosis of A-fib in the clinic; however, due to irregular occurrence of A-fib (i.e., intermittent occurrence), an ECG monitoring for 24 h or more has to be performed to detect episodes. In a considerable number of cases the monitoring with a Holter system fails to detect episodes of A-fib, with a subsequent increase in risk for the development of consecutive stroke. In addition, such monitoring techniques for detection of A-fib are expensive and cumbersome. The device used (Everion) in this trial enables a non-invasive continuous monitoring of vital signs and has a valid CE-mark. If algorithm based analysis of CVSM shows sufficient
performance in detecting for example A-fib, it could be used to automatically analyze vital sign data obtained by e.g. fitness trackers with same features as the device to check for the likelihood of arrhythmias.

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Organizational Data

  •   DRKS00014821
  •   2018/06/05
  •   [---]*
  •   yes
  •   Approved
  •   02/2018, Ethik-Kommission der Universität Witten/Herdecke
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   I48.0 -  Paroxysmal atrial fibrillation
  •   I47.0 -  Re-entry ventricular arrhythmia
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Interventions/Observational Groups

  •   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.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

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.

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Secondary Outcome

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.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2018/06/06
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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

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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

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Addresses

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    • Universität Witten/Herdecke
    • Mr.  Dr.  Malte  Jacobsen 
    • Alfred-Herrhausenstraße 50
    • 58448  Witten
    • Germany
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    • Helios Universitätsklinikum Wuppertal
    • Mr.  Dr.  Malte  Jacobsen 
    • Heusner Str. 40
    • 42283  Wuppertal
    • Germany
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    • Helios Universitätsklinikum Wuppertal
    • Mr.  Dr.  Malte  Jacobsen 
    • Heusner Str. 40
    • 42283  Wuppertal
    • Germany
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Sources of Monetary or Material Support

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    • Helios Forschungsförderung -Helios Universitätsklinikum Wuppertal
    • Ms.  Prof. Dr.  Petra  Thürmann 
    • Heusnerstraße 40
    • 42283  Wuppertal
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.