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

NCT ID: NCT04579159

Last Updated: 2022-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 882 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-26
• Study Completion Date: 2022-02-25

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.

Conditions

Atrial Arrhythmia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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).

Group Type: OTHER

Preventicus heartbeat app in combination with wearables

Intervention Type: DEVICE

CE certified devices

Interventions

Preventicus heartbeat app in combination with wearables

CE certified devices

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

INDUSTRY

Sponsor Role: collaborator

Preventicus GmbH

INDUSTRY

Sponsor Role: collaborator

Corsano/ MMT

UNKNOWN

Sponsor Role: collaborator

Getemed Medizin- und Informationstechnik

UNKNOWN

Sponsor Role: collaborator

Atrial Fibrillation Network

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Larissa Fabritz, Professor

Role: PRINCIPAL_INVESTIGATOR

Institute of Cardiovascular Sciences, University of Birmingham

Locations

Universitäres Herz- und Gefäßzentrum UKE Hamburg

Hamburg, , Germany

Kardiologische Praxis, Dr. med. Jens Taggeselle

Markkleeberg, , Germany

Krakowskie Centrum Diagnostyczno-Kliniczne (KCDK)

Krakow, , Poland

Hospital Clínic Unitat d'Arrítmies, Institut Cardiovascular

Barcelona, Catalonia, Spain

Countries

Germany; Poland; Spain

References

Fabritz L, Connolly DL, Czarnecki E, Dudek D, Guasch E, Haase D, Huebner T, Zlahoda-Huzior A, Jolly K, Kirchhof P, Obergassel J, Schotten U, Vettorazzi E, Winkelmann SJ, Zapf A, Schnabel RB; Smart in OAC-AFNET 9 investigators. Smartphone and wearable detected atrial arrhythmias in Older Adults: Results of a fully digital European Case finding study. Eur Heart J Digit Health. 2022 Nov 1;3(4):610-625. doi: 10.1093/ehjdh/ztac067. eCollection 2022 Dec.

Reference Type: DERIVED

PMID: 36710894 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35387433 (View on PubMed)

Other Identifiers

Smart in OAC - AFNET 9

Identifier Type: -

Identifier Source: org_study_id