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
About this trial
This is an interventional screening trial for Atrial Fibrillation
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
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
NCT ID
NCT05914883
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
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
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