NCT04579159

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
882

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

January 26, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2022

Completed
Last Updated

July 7, 2022

Status Verified

July 1, 2022

Enrollment Period

1.1 years

First QC Date

September 8, 2020

Last Update Submit

July 4, 2022

Conditions

Atrial Arrhythmia

Outcome Measures

Primary Outcomes (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

    Screening per participant: 4-8 weeks

Secondary Outcomes (8)

  • 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

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

  • 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

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

  • Duration of atrial arrhythmia episodes

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

  • +3 more secondary outcomes

Study Arms (1)

only control group

OTHER

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

Interventions

Preventicus heartbeat app in combination with wearablesDEVICE

CE certified devices

only control group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Known AF
  • Known current or planned oral anticoagulation treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Universitäres Herz- und Gefäßzentrum UKE Hamburg

Hamburg, Germany

Location

Kardiologische Praxis, Dr. med. Jens Taggeselle

Markkleeberg, 04416, Germany

Location

Krakowskie Centrum Diagnostyczno-Kliniczne (KCDK)

Krakow, 31-514, Poland

Location

Hospital Clínic Unitat d'Arrítmies, Institut Cardiovascular

Barcelona, Catalonia, 08036, Spain

Location

Related Publications (2)

  • 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.

    PMID: 36710894DERIVED

  • 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.

    PMID: 35387433DERIVED

Study Officials

  • Larissa Fabritz, Professor

    Institute of Cardiovascular Sciences, University of Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2020

First Posted

October 8, 2020

Study Start

January 26, 2021

Primary Completion

February 25, 2022

Study Completion

February 25, 2022

Last Updated

July 7, 2022

Record last verified: 2022-07

Locations

DE(2)PL(1)ES(1)