Actively Recruiting
The Southern-Norway Post-Stroke Atrial Fibrillation Study
Led by Sorlandet Hospital HF · Updated on 2026-02-12
450
Participants Needed
1
Research Sites
203 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study evaluates whether a procedure using a new wireless heart sensor patch is equal to or better than the standard hospital procedures and equipment at detecting an irregular heartbeat called Atrial Fibrillation (AF) after an ischemic stroke. Atrial fibrillation is a major cause of stroke, but it can be difficult to catch because it often comes and goes. The study will include approximately 450 adults who have had a stroke or a transient "mini-stroke" (TIA) within the last two weeks. Participants will be assigned by chance (randomized) to one of two groups: * Group 1 (Intervention): Participants wear the "ECG247 Smart Heart Sensor." This is a small patch that sticks to the chest and connects to a smartphone. It is worn continuously for up to 14 days, even after leaving the hospital. * Group 2 (Standard Care): Participants receive the standard hospital check-up. This typically involves using a "Holter monitor" (a device with wires and electrodes) for a period of about 24 to 48 hours some time after leaving the hospital. The main goal is to see if the procedure using the patch is equal to the standard procedure in detecting atrial fibrillation in participants. The study will also measure how quickly doctors can start the correct medication and how easy the patients find the devices to use.
CONDITIONS
Official Title
The Southern-Norway Post-Stroke Atrial Fibrillation Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients hospitalized with an ischemic stroke or transient ischemic attack (TIA), including amaurosis fugax, within the last 2 weeks
- Diagnosis supported by CT, CT angiography, or MRI confirming TIA or ischemic stroke
- Access to a smartphone and ability to use the ECG247 app
- Estimated life expectancy longer than 6 months
- Permanent residence in Norway
- Ability to provide informed consent personally or via proxy as per study protocol
You will not qualify if you...
- Known atrial fibrillation or atrial flutter before joining the study
- Current use of anticoagulant medicines or contraindication to anticoagulation treatment
- Having an implanted pacemaker, implantable cardioverter defibrillator (ICD), or loop recorder
- More than 70% narrowing of the carotid artery on the same side as the stroke
- Pregnancy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sørlandet Sykehus HF
Kristiansand, Norway, 4615
Actively Recruiting
Research Team
H
Halvor Oeygarden, PhD
CONTACT
I
Ivana Sapina, PhD student
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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