search
Back to results

The NORwegian Atrial Fibrillation Self-SCREENing (NORSCREEN)

Primary Purpose

Atrial Fibrillation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Long-term continuous ECG monitoring
Sponsored by
Sorlandet Hospital HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Atrial Fibrillation

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age ≥65 years and minimum one other risk factor for stroke according to the CHA2DS2-VASc risk score: Age ≥75 years, Diabetes, Heart failure, Hypertension, Previous stroke/TIA and/or Vascular disease Informed consent for participation Exclusion Criteria: History of AF (self-reported) Use of anticoagulation therapy Pacemaker/CRT device No smart phone

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    ECG screening

    No ECG screening

    Arm Description

    Outcomes

    Primary Outcome Measures

    Stroke
    all-cause

    Secondary Outcome Measures

    Full Information

    First Posted
    June 8, 2023
    Last Updated
    June 19, 2023
    Sponsor
    Sorlandet Hospital HF
    Collaborators
    Oslo University Hospital, Haukeland University Hospital, St. Olavs Hospital, University Hospital of North Norway
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05914883
    Brief Title
    The NORwegian Atrial Fibrillation Self-SCREENing
    Acronym
    NORSCREEN
    Official Title
    The NORwegian Atrial Fibrillation Self-SCREENing
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 15, 2023 (Anticipated)
    Primary Completion Date
    December 2029 (Anticipated)
    Study Completion Date
    December 31, 2029 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sorlandet Hospital HF
    Collaborators
    Oslo University Hospital, Haukeland University Hospital, St. Olavs Hospital, University Hospital of North Norway

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Atrial fibrillation (AF) is common, increases the risk of mortality, stroke and heart failure, and portending significant burden to patients, societal health and health economy. One of three AF cases are undiagnosed. Several methods for detection of AF exist, but most of them have major limitations and are associated with resource-demanding diagnostic workup in the speciality health care services. This randomized clinical trial will evaluate whether self-screening for AF with the ECG247 patch monitor will reduce AF-related morbidity.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atrial Fibrillation

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    20000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ECG screening
    Arm Type
    Experimental
    Arm Title
    No ECG screening
    Arm Type
    No Intervention
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Long-term continuous ECG monitoring
    Intervention Description
    Long-term continuous ECG monitoring with ECG247 Smart Heart Sensor
    Primary Outcome Measure Information:
    Title
    Stroke
    Description
    all-cause
    Time Frame
    5 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age ≥65 years and minimum one other risk factor for stroke according to the CHA2DS2-VASc risk score: Age ≥75 years, Diabetes, Heart failure, Hypertension, Previous stroke/TIA and/or Vascular disease Informed consent for participation Exclusion Criteria: History of AF (self-reported) Use of anticoagulation therapy Pacemaker/CRT device No smart phone
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jarle Jortveit, PhD
    Phone
    +4799450714
    Email
    jarle.jortveit@sshf.no
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sigrun Halvorsen, PhD
    Organizational Affiliation
    Oslo University Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The NORwegian Atrial Fibrillation Self-SCREENing

    We'll reach out to this number within 24 hrs