The NORwegian Atrial Fibrillation Self-SCREENing

Atrial Fibrillation Clinical Trial

— NORSCREEN  

Official title:

The NORwegian Atrial Fibrillation Self-SCREENing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05914883
• Other study ID #: 477781
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: December 31, 2029

Study information

• Verified date: November 2023
• Source: Sorlandet Hospital HF
• Contact: Jarle Jortveit, PhD
• Phone: +4799450714
• Email: jarle.jortveit[@]sshf.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: December 31, 2029
• Est. primary completion date: December 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Diagnostic Test:
• Long-term continuous ECG monitoring
Long-term continuous ECG monitoring with ECG247 Smart Heart Sensor

Locations

Country	Name	City	State
Norway	Sorlandet Hospital	Arendal

Sponsors (5)

Lead Sponsor	Collaborator
Sorlandet Hospital HF	Haukeland University Hospital, Oslo University Hospital, St. Olavs Hospital, University Hospital of North Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stroke	all-cause	5 years