The South-Norway Atrial Fibrillation Screening Study

NCT04700865 | Completed

• 1 other identifier: 20/09000-7
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

Atrial fibrillation (AF) is the most common sustained cardiac rhythm disorder. The most serious common complication of AF is ischemic stroke.The aim of this study is to investigate the yield of AF screening with a continuous ECG monitor (ECG247) and to estimate the prevalence of silent AF

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Prevalence of AF

  AF during procedure

  During procedure

Study Arms (1)

Examination

OTHER

Continuous ECG monitoring for minimum 3 days

Diagnostic Test: AF screening

Interventions

AF screening DIAGNOSTIC_TEST

Continous ECG monitoring for minimum 3 days

Examination

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age \>65 years
• Diabetes, heart failure, hypertension, previous stroke/TIA or other cardiovascular disease (minimum 1 risk factor)
• Informed written consent for participation

You may not qualify if:

• Chronic AF
• Lack of ability to cooperate

Sponsors & Collaborators

• Sorlandet Hospital HF: lead

Study Sites (1)

Sorlandet Hospital

Arendal, 4809, Norway

Location

Related Publications (6)

• Sandberg EL, Halvorsen S, Berge T, Grimsmo J, Atar D, Leangen Grenne B, Jortveit J. Digital recruitment and compliance to treatment recommendations in the Norwegian Atrial Fibrillation self-screening pilot study. Eur Heart J Digit Health. 2024 Apr 9;5(3):371-378. doi: 10.1093/ehjdh/ztae026. eCollection 2024 May.

  PMID: 38774377 DERIVED

• Sandberg EL, Halvorsen S, Berge T, Grimsmo J, Atar D, Grenne BL, Jortveit J. Screening for Atrial Fibrillation by Digital Health Technology in Older People in Homecare Settings: A Feasibility Trial. Int J Telemed Appl. 2024 Mar 25;2024:4080415. doi: 10.1155/2024/4080415. eCollection 2024.

  PMID: 38567031 DERIVED

• Jortveit J, Boskovic M, Sandberg EL, Vegsundvag J, Halvorsen S. High Diagnostic Accuracy of Long-Term Electrocardiogram Interpretation by General Practitioners. Int J Telemed Appl. 2024 Feb 22;2024:6624344. doi: 10.1155/2024/6624344. eCollection 2024.

  PMID: 38425473 DERIVED

• Sandberg EL, Halvorsen S, Berge T, Grimsmo J, Atar D, Fensli R, Grenne BL, Jortveit J. Fully digital self-screening for atrial fibrillation with patch electrocardiogram. Europace. 2023 May 19;25(5):euad075. doi: 10.1093/europace/euad075.

  PMID: 36945146 DERIVED

• Jortveit J, Fensli R. Remote ECG Monitoring by ECG247 Smart Heart Sensor. Int J Telemed Appl. 2022 Feb 11;2022:6812889. doi: 10.1155/2022/6812889. eCollection 2022.

  PMID: 35186075 DERIVED

• Sandberg EL, Grenne BL, Berge T, Grimsmo J, Atar D, Halvorsen S, Fensli R, Jortveit J. Diagnostic Accuracy and Usability of the ECG247 Smart Heart Sensor Compared to Conventional Holter Technology. J Healthc Eng. 2021 Nov 2;2021:5230947. doi: 10.1155/2021/5230947. eCollection 2021.

  PMID: 34765102 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jarle Jortveit, PhD

  Sorlandet Hospital Arendal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2020
• First Posted: January 8, 2021
• Study Start: December 23, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: December 5, 2022

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)