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Completed

NCT Number: NCT04579159

The Smartphone and Wearable Detected Atrial Arrhythmia in Older Adults Case Finding Study (Smart in OAC - AFNET 9)

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.

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Key information

Conditions

Atrial Arrhythmia

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitäres Herz- und Gefäßzentrum UKE Hamburg, Hamburg, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preventicus heartbeat app in combination with wearables

Device

CE certified devices

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Atrial Fibrillation Network

Other

Collaborators

  • Corsano/ MMT
  • Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
  • Getemed Medizin- und Informationstechnik
  • Preventicus GmbH

Registry information

Official study 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

Acronym: Smart in OAC

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 8, 2020
Registry last updated
Jul 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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