Clinical trial NCT04579159: The Smartphone and Wearable Detected Atrial Arrhythmia in Older Adults Case Finding Study (Smart in OAC - AFNET 9)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Arrhythmia
Lead sponsor: Atrial Fibrillation Network
Sponsor class: OTHER
Collaborators: name: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
name: Preventicus GmbH
name: Corsano/ MMT
name: Getemed Medizin- und Informationstechnik
First posted: 2020-10-08
Enrollment: 882
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

Eligibility 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

Primary outcomes:
measure: Proportion of participants with newly detected AA within 4 weeks of device use of all participants included in the study
timeFrame: Screening per participant: 4-8 weeks
Secondary outcomes:
measure: Propotion of participants with AA detected at any time, including those with AA detected within the full time of recording
timeFrame: Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months
measure: Time from completed enrolment to the first positive screening, taking death as compeeting risk into account
timeFrame: Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months
measure: Regional differences of AA prevalance (diagnostic yield)
timeFrame: Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months
measure: Differences by rout fo invitation and enrolment
timeFrame: Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months
measure: Duration of atrial arrhythmia episodes
timeFrame: Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months
measure: Follow-up EQ-5DL-5L viscual analogue scale of participants with positve PPG
timeFrame: Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months
measure: Detection of AF: Number of participants with clinically confirmed arrhythmias during Holter ECG
timeFrame: Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months
measure: Compliance: The compliance of participants with protocol with regards to the measurement procedure of the app and wearable
timeFrame: Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Universitäres Herz- und Gefäßzentrum UKE Hamburg
city: Markkleeberg
country: Germany
facility: Kardiologische Praxis, Dr. med. Jens Taggeselle
city: Kraków
country: Poland
facility: Krakowskie Centrum Diagnostyczno-Kliniczne (KCDK)
city: Barcelona
country: Spain
facility: Hospital Clínic Unitat d'Arrítmies, Institut Cardiovascular
state: Catalonia
Study officials:
affiliation: Institute of Cardiovascular Sciences, University of Birmingham
name: Larissa Fabritz, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.