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

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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Arrhythmia
• Intervention / Treatment: Device: Preventicus heartbeat app in combination with wearables

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: Interventional
• Enrollment (Actual): 882
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany
    • Universitäres Herz- und Gefäßzentrum UKE Hamburg
  • Markkleeberg, Germany, 04416
    • Kardiologische Praxis, Dr. med. Jens Taggeselle
• Poland
  • Kraków, Poland, 31-514
    • Krakowskie Centrum Diagnostyczno-Kliniczne (KCDK)
• Spain
  • Catalonia
    • Barcelona, Catalonia, Spain, 08036
      • Hospital Clínic Unitat d'Arrítmies, Institut Cardiovascular

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 61 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with newly detected AA within 4 weeks of device use of all participants included in the study	Proportion of participants with newly detected AA within 4 weeks of device use of all participants included in the study	Screening per participant: 4-8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Propotion of participants with AA detected at any time, including those with AA detected within the full time of recording	Propotion of participants with AA detected at any time, including those with AA detected within the full time of recording	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	Time from completed enrolment to the first positive screening, taking death as compeeting risk into account	Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months
Regional differences of AA prevalance (diagnostic yield)	Regional differences of AA prevalance (diagnostic yield)	Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months
Differences by rout fo invitation and enrolment	Differences by rout fo invitation and enrolment	Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months
Duration of atrial arrhythmia episodes	Duration of atrial arrhythmia episodes will be reported descriptively by mean, sd, range, median and IQR	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	Follow-up EQ-5DL-5L viscual analogue scale of participants with positve PPG	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	Detection of AF: Number of participants with clinically confirmed arrhythmias during Holter ECG, documented clinically or by event-recorder	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	Compliance: The compliance of participants with protocol with regards to the measurement procedure of the app and wearable will be presented descriptively	Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months

Collaborators and Investigators

• Sponsor: Atrial Fibrillation Network
• Collaborators: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company; Preventicus GmbH; Corsano/ MMT; Getemed Medizin- und Informationstechnik
• Investigators: Principal Investigator: Larissa Fabritz, Professor, Institute of Cardiovascular Sciences, University of Birmingham

Publications and helpful links

General Publications

• Fabritz L, Connolly D, Czarnecki E, Dudek D, Zlahoda-Huzior A, Guasch E, Haase D, Huebner T, Jolly K, Kirchhof P, Schotten U, Zapf A, Schnabel RB. Remote Design of a Smartphone and Wearable Detected Atrial Arrhythmia in Older Adults Case Finding Study: Smart in OAC - AFNET 9. Front Cardiovasc Med. 2022 Mar 21;9:839202. doi: 10.3389/fcvm.2022.839202. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2021
• Primary Completion (Actual): February 25, 2022
• Study Completion (Actual): February 25, 2022

Study Registration Dates

• First Submitted: September 8, 2020
• First Submitted That Met QC Criteria: September 30, 2020
• First Posted (Actual): October 8, 2020

Study Record Updates

• Last Update Posted (Actual): July 7, 2022
• Last Update Submitted That Met QC Criteria: July 4, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: Smart in OAC - AFNET 9

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No