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Atrial ArrhythmiaSmart in OACNCT04579159

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

A study testing Preventicus heartbeat app in combination with wearables in people with Atrial Arrhythmia, run by Atrial Fibrillation Network at 4 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Atrial Arrhythmia
What is being tested?
Preventicus heartbeat app in combination with wearables
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
882 participants
Where
4 sitesin 3 countries
Study dates
26 Jan 2021to 25 Feb 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 65 years or older
  • Willing and able to provide informed consent
  • Owning mobile phone compatible with the PPG-wearable

Who cannot join

  • Known AF
  • Known current or planned oral anticoagulation treatment

Trial locations and contacts

4 sites in 3 countries.

4 sites in 3 countries

Germany2 sites

  • Universitäres Herz- und Gefäßzentrum UKE Hamburg

    Hamburg

  • Kardiologische Praxis, Dr. med. Jens Taggeselle

    Markkleeberg, 04416

Other trials in Germany

Poland1 site

  • Krakowskie Centrum Diagnostyczno-Kliniczne (KCDK)

    Krakow, 31-514

Other trials in Poland

Spain1 site

  • Hospital Clínic Unitat d'Arrítmies, Institut Cardiovascular

    Barcelona, Catalonia, 08036

Other trials in Spain

About this study

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

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.

Read the 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.

Being tested
Preventicus heartbeat app in combination with wearables

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Preventicus heartbeat app in combination with wearablesDevice

    CE certified devices

Study groups in NCT04579159
Study groupRoleWhat they receive
only control groupOtherTo 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).
Receives: Device: Preventicus heartbeat app in combination with wearables

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Screening per participant: 4-8 weeks

Secondary outcomes (8)

  1. 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

    Measured: Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months

  2. 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

    Measured: Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months

  3. Regional differences of AA prevalance (diagnostic yield)

    Regional differences of AA prevalance (diagnostic yield)

    Measured: Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months

  4. Differences by rout fo invitation and enrolment

    Differences by rout fo invitation and enrolment

    Measured: Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months

  5. Duration of atrial arrhythmia episodes

    Duration of atrial arrhythmia episodes will be reported descriptively by mean, sd, range, median and IQR

    Measured: Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months

  6. 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

    Measured: Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months

  7. 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

    Measured: Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months

  8. 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

    Measured: Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2020
  2. Study start26 Jan 2021
  3. Primary completion25 Feb 2022
  4. Study completion25 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
882 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04579159
Sponsor's protocol ID
Smart in OAC - AFNET 9
Acronym
Smart in OAC
Status last verified
Jul 2022
First submitted
8 Sep 2020
Last updated
7 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 36710894

  • 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.

    PubMed 35387433

Questions about this trial

What is this clinical trial studying?

A study testing Preventicus heartbeat app in combination with wearables in people with Atrial Arrhythmia, run by Atrial Fibrillation Network at 4 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Germany, Poland, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04579159, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2022.

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