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Trial record 1 of 1 for:    NCT04579159
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The Smartphone and Wearable Detected Atrial Arrhythmia in Older Adults Case Finding Study (Smart in OAC - AFNET 9) (Smart in OAC)

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ClinicalTrials.gov Identifier: NCT04579159
Recruitment Status : Completed
First Posted : October 8, 2020
Last Update Posted : July 7, 2022
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Atrial Arrhythmia Device: Preventicus heartbeat app in combination with wearables Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 882 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: 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
Actual Study Start Date : January 26, 2021
Actual Primary Completion Date : February 25, 2022
Actual Study Completion Date : February 25, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia

Arms and Interventions
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Arm Intervention/treatment
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).
 Device: Preventicus heartbeat app in combination with wearables
CE certified devices


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of participants with newly detected AA within 4 weeks of device use of all participants included in the study [ Time Frame: Screening per participant: 4-8 weeks ]
    Proportion of participants with newly detected AA within 4 weeks of device use of all participants included in the study


Secondary Outcome Measures :
  1. Propotion of participants with AA detected at any time, including those with AA detected within the full time of recording [ Time Frame: Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months ]
    Propotion of participants with AA detected at any time, including those with AA detected within the full time of recording

  2. Time from completed enrolment to the first positive screening, taking death as compeeting risk into account [ Time Frame: Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months ]
    Time from completed enrolment to the first positive screening, taking death as compeeting risk into account

  3. Regional differences of AA prevalance (diagnostic yield) [ Time Frame: Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months ]
    Regional differences of AA prevalance (diagnostic yield)

  4. Differences by rout fo invitation and enrolment [ Time Frame: Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months ]
    Differences by rout fo invitation and enrolment

  5. Duration of atrial arrhythmia episodes [ Time Frame: Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months ]
    Duration of atrial arrhythmia episodes will be reported descriptively by mean, sd, range, median and IQR

  6. Follow-up EQ-5DL-5L viscual analogue scale of participants with positve PPG [ Time Frame: Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months ]
    Follow-up EQ-5DL-5L viscual analogue scale of participants with positve PPG

  7. Detection of AF: Number of participants with clinically confirmed arrhythmias during Holter ECG [ Time Frame: Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months ]
    Detection of AF: Number of participants with clinically confirmed arrhythmias during Holter ECG, documented clinically or by event-recorder

  8. Compliance: The compliance of participants with protocol with regards to the measurement procedure of the app and wearable [ Time Frame: Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months ]
    Compliance: The compliance of participants with protocol with regards to the measurement procedure of the app and wearable will be presented descriptively


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04579159


Locations
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Germany
Universitäres Herz- und Gefäßzentrum UKE Hamburg
Hamburg, Germany
Kardiologische Praxis, Dr. med. Jens Taggeselle
Markkleeberg, Germany, 04416
Poland
Krakowskie Centrum Diagnostyczno-Kliniczne (KCDK)
Kraków, Poland, 31-514
Spain
Hospital Clínic Unitat d'Arrítmies, Institut Cardiovascular
Barcelona, Catalonia, Spain, 08036
Sponsors and Collaborators
Atrial Fibrillation Network
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Preventicus GmbH
Corsano/ MMT
Getemed Medizin- und Informationstechnik
Investigators
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Principal Investigator: Larissa Fabritz, Professor Institute of Cardiovascular Sciences, University of Birmingham
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Atrial Fibrillation Network
ClinicalTrials.gov Identifier: NCT04579159    
Other Study ID Numbers: Smart in OAC - AFNET 9
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: July 7, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes