NORSCREEN: The NORwegian Atrial Fibrillation Self-SCREENing

Sponsor

Sorlandet Hospital HF (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05914883

Collaborator

Oslo University Hospital (Other), Haukeland University Hospital (Other), St. Olavs Hospital (Other), University Hospital of North Norway (Other)

20,000

Enrollment

Arms

76.6

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Diagnostic Test: Long-term continuous ECG monitoring	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Screening

Official Title:

The NORwegian Atrial Fibrillation Self-SCREENing

Anticipated Study Start Date :

Aug 15, 2023

Anticipated Primary Completion Date :

Dec 1, 2029

Anticipated Study Completion Date :

Dec 31, 2029

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ECG screening	Diagnostic Test: Long-term continuous ECG monitoring Long-term continuous ECG monitoring with ECG247 Smart Heart Sensor
No Intervention: No ECG screening

Arm

Intervention/Treatment

Experimental: ECG screening

Diagnostic Test: Long-term continuous ECG monitoring

Long-term continuous ECG monitoring with ECG247 Smart Heart Sensor

No Intervention: No ECG screening

Outcome Measures

Primary Outcome Measures

Stroke [5 years]
all-cause

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Sorlandet Hospital HF
Oslo University Hospital
Haukeland University Hospital
St. Olavs Hospital
University Hospital of North Norway

Investigators

Study Chair: Sigrun Halvorsen, PhD, Oslo University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sorlandet Hospital HF

ClinicalTrials.gov Identifier:

NCT05914883

Other Study ID Numbers:

477781

First Posted:

Jun 22, 2023

Last Update Posted:

Jun 22, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Atrial Fibrillation

Study Results

No Results Posted as of Jun 22, 2023