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Trial record 1 of 1 for:    NCT04579159
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Case-finding Study to Detect and Quantify Episodes of Absolute Arrhythmia Using an Automated, Wearable Monitoring System (Smart in OAC)

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ClinicalTrials.gov Identifier: NCT04579159
Recruitment Status : Recruiting
First Posted : October 8, 2020
Last Update Posted : March 8, 2021
Sponsor:
Collaborators:
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Preventicus GmbH
Corsano/ MMT
Getemed Medizin- und Informationstechnik
Information provided by (Responsible Party):
Atrial Fibrillation Network

Tracking Information
First Submitted Date  ICMJE September 8, 2020
First Posted Date  ICMJE October 8, 2020
Last Update Posted Date March 8, 2021
Actual Study Start Date  ICMJE January 26, 2021
Estimated Primary Completion Date January 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2021)
Prevalence of AA measured as number of participants with AA detected by the wearable in relation to all included participants [ Time Frame: Screening per participant: 8 weeks ]
Prevalence of AA measured as number of participants with AA detected by the wearable in relation to all included participants
Original Primary Outcome Measures  ICMJE
 (submitted: September 30, 2020)
Prevalence of AA measured as number of participants with AA detected by the wearable in relation to all included participants [ Time Frame: Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months ]
Prevalence of AA measured as number of participants with AA detected by the wearable in relation to all included participants
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2020)
  • Rate of participants with newly detected Atrial Arrhythmia [ Time Frame: Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months ]
    Rate of participants with newly detected Atrial Arrhythmia by the wearable
  • Proportion of participants with AA contacting the study centre [ Time Frame: Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months ]
    Proportion of participants with AA contacting the study centre in relation to all participants with detected AA
  • Number of participants wearing the 14 day Tele ECG patch after detection of AA [ Time Frame: Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months ]
    Number of participants wearing the 14 day Tele ECG patch after detection of AA by the wearable
  • Number of participants enrolled per day/week [ Time Frame: Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months ]
    Number of participants enrolled per day/week
  • Number of participants with arrhythmias (sub-analysis: AF) confirmed by 14 day Tele ECG [ Time Frame: Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months ]
    Number of participants with arrhythmias (sub-analysis: AF) confirmed by 14 day Tele ECG
  • Sensitivity and specificity regarding the diagnosis of arrhythmia [ Time Frame: Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months ]
    Sensitivity and specificity regarding the diagnosis of arrhythmia in subgroup of participants with and without wearable-detected Atrial Arrhythmia with ECG-confirmed diagnosis
  • Duration: The duration from start of measurement to the first positive screening result and from the start of the 14 day Tele ECG to the first episode of AF [ Time Frame: Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months ]
    Duration: The duration from start of measurement to the first positive screening result technically verified by Telecare and from the start of the 14 day Tele ECG to the first episode of AF verified by Telecare
  • Geographical effects: Regional differences of AA prevalence (diagnostic yield) and differences by screening route [ Time Frame: Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months ]
    Geographical effects: Regional differences of AA prevalence (diagnostic yield) and differences by screening route
  • Compliance of participants using the app/wearable: percentage of active users after two weeks [ Time Frame: Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months ]
    Compliance of participants using the app/wearable: percentage of active users after two weeks assessed by Telecare
  • Duration of AA episodes and AA burden (time in AA / monitored time) verified by Telecare [ Time Frame: Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months ]
    Duration of AA episodes and AA burden (time in AA / monitored time) verified by Telecare
  • EQ-5D-5L visual analogue scale [ Time Frame: Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months ]
    EQ-5D-5L visual analogue scale: Qualtiy of life measured by the scale
  • Recommendation for change in medication [ Time Frame: Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months ]
    Recommendation for change in medication after ECG screening
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Case-finding Study to Detect and Quantify Episodes of Absolute Arrhythmia Using an Automated, Wearable Monitoring System
Official Title  ICMJE Multicentre, Intern., Inv.-Initiated, Single-arm Case-finding Study of a Cloud Based Analytic Service as Screening Tool to Detect and Quantify Episodes of Absolute Arrhythmia Using an Automated, Wearable PPG-based Monitoring System
Brief Summary This feasibility study will develop and evaluate pathways to identify participants with wearable-detected absoulute Arrhythmia (AA) and to enable local study teams to contact them regarding participation in a controlled trial of oral anticoagulation in this population, which will be conducted after the feasibility study.
Detailed Description In this study, the feasibility of evaluating the efficacy of a cloud based analytic service in combination with a PPG-wearable in detecting AA will be assessed and the number of cases found. The design aims to provide simple, low-threshold access to this screening technology targeting at-risk populations. This study will not cause any restrictions on the usual care of the study participants. Access to the screening will be provided close to home and free of charge. The app will also be used to validate and enhance the clinical information about the participants captured during the study. This information will be used to define and refine target groups with highest screening efficiency and, in the long-term, outcome benefits. The study will describe the prevalence of AA in an unselected population that can be reached by a low-threshold screening procedure. The study will also generate important information on the different possible screening environments in different countries (e.g. pharmacies, GP practices, etc). Structures of work-up and continuous patient management in screen-positive individuals will be described and may help to design screening pathways in the main trial. By verifying the wearable-diagnoses by ECG in all screen-positive and a random selection of screen-negative participants, the diagnostic accuracy of the wearable in combination of cloud based analytic service can be estimated. Cost effectiveness assessment will evaluate the cost of low-threshold remote screening per patient identified and help guide to target high risk groups with optimal screening yield in the future. The collected data will provide the sound basis for the design and conduct of a large outcome trial.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Atrial Arrhythmia
Intervention  ICMJE Device: Preventicus heartbeat app in combination with wearables
CE certified devices
Study Arms  ICMJE only control group
To investigate the specificity of the wearable and to gather more information on ECG abnormalities in the population studied, a randomly selected group of participants without wearable-detected AA within 8 weeks of screening (same number as screen-positives and verified by Telecare) will also be invited to obtain a 14day Tele ECG (patch).
Intervention: Device: Preventicus heartbeat app in combination with wearables
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 30, 2020)
2000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2022
Estimated Primary Completion Date January 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Inclusion criteria:

  • 65 years or older
  • Willing and able to provide informed consent
  • Owning mobile phone compatible with the PPG-wearable

Exclusion criteria:

  • Known AF
  • Known current or planned oral anticoagulation treatment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Emilia Czarnecki +49 (0)251-980-1340 emilia.czarnecki@af-net.eu
Contact: Alexandra Simbrich +49 (0)251-980-1345 alexandra.simbrich@af-net.eu
Listed Location Countries  ICMJE Germany,   Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04579159
Other Study ID Numbers  ICMJE Smart in OAC - AFNET 9
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Atrial Fibrillation Network
Study Sponsor  ICMJE Atrial Fibrillation Network
Collaborators  ICMJE
  • Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
  • Preventicus GmbH
  • Corsano/ MMT
  • Getemed Medizin- und Informationstechnik
Investigators  ICMJE
Principal Investigator: Larissa Fabritz, Professor Institute of Cardiovascular Sciences, University of Birmingham
PRS Account Atrial Fibrillation Network
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP