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

Atrial Arrhythmia Clinical Trial

— Smart in OAC  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04579159
• Other study ID #: Smart in OAC - AFNET 9
• Status: Completed
• Phase: N/A
• Start date: January 26, 2021
• Est. completion date: February 25, 2022

Study information

• Verified date: July 2022
• Source: Atrial Fibrillation Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 882
• Est. completion date: February 25, 2022
• Est. primary completion date: February 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Arrhythmia

Intervention

Device:
• Preventicus heartbeat app in combination with wearables
CE certified devices

Locations

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

Sponsors (5)

Lead Sponsor	Collaborator
Atrial Fibrillation Network	Corsano/ MMT, Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company, Getemed Medizin- und Informationstechnik, Preventicus GmbH

Countries where clinical trial is conducted

Germany,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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