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Status:

COMPLETED

A Study to Assess the Effectiveness of an Atrial Fibrillation (AF) Risk Prediction Algorithm and Diagnostic Test in Identifying Patients With AF.

Lead Sponsor:

Bristol-Myers Squibb

Conditions:

Atrial Fibrillation

Eligibility:

All Genders

30+ years

Brief Summary

This is a trial to assess the effectiveness of an atrial fibrillation (AF) risk prediction algorithm and diagnostic test for the identification of patients with atrial fibrillation

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Practice inclusion criteria for the trial are as follows;
  • GP Practices within National Institute for Healthcare Research (NIHR) Clinical Research Network: West Midlands (CRN: WM) CRN: WM
  • GP Practices using EMIS as their electronic medical record system of choice. Patient inclusion criteria for the trial are as follows;
  • Patients registered at a participating practice, aged ≥30 years and without an AF diagnosis.
  • Patients with a valid index date (see Section 3.3) Participant inclusion criteria for participation in the intervention arm are;
  • As above, and who have provided written consent to: attend a research clinic, AF diagnosis check using a 12-lead ECG, and for access to medical records Participant inclusion criteria for participation in further AF remote diagnosis with an AliveCor Heart Monitor are;
  • As above, and those with a negative or indeterminant ECG
  • As above, and those with access to a smartphone
  • Exclusion criteria:
  • Patients \<30 years
  • Patients with an existing diagnosis of AF
  • Patients for whom the healthcare professional feels the study is unsuitable

Exclusion

    Key Trial Info

    Start Date :

    June 30 2019

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    January 12 2021

    Estimated Enrollment :

    260 Patients enrolled

    Trial Details

    Trial ID

    NCT04045639

    Start Date

    June 30 2019

    End Date

    January 12 2021

    Last Update

    August 2 2021

    Active Locations (6)

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    Page 1 of 2 (6 locations)

    1

    Local Institution

    Ludlow, United Kingdom, SY8 2AB

    2

    Local Institution

    Royal Leamington Spa, United Kingdom, CV32 4RA

    3

    Local Institution

    Shropshire, United Kingdom, SY11 1RD

    4

    Local Institution

    Warkwickshire, United Kingdom, B49 6QR