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NCT07407790Recruiting

The Southern-Norway Post-Stroke Atrial Fibrillation Study

Source: ClinicalTrials.gov · Last updated 12 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
450 (estimated)
First submitted
25 Jan 2026
Start date
10 Jan 2026
Primary completion date
Dec 2028
Lead sponsor
Sorlandet Hospital HF
NCT number
NCT07407790

What you commit to

  • Study type: Interventional
  • Planned participants: 450
  • From 10 Jan 2026 to the primary completion date, Dec 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Known AF or atrial flutter prior to inclusion
  • Concomitant use of anticoagulation therapy or established contraindication to its use. To date this includes apixaban, rivaroxaban, edoxaban, dabigatran, warfarin and indirect thrombin inhibitors (except for short term thrombosis prevention).

Other illness

  • Medical Conditions
  • \>70% stenosis of carotid artery on ipsilateral side to the stroke on CT angiography or ultrasound

Other

  • Participants are excluded from the study if any of the following criteria apply:
  • Implanted pacemaker, ICD or loop-recorder
  • Pregnancy

Who the study is looking for

  • Patients hospitalized with an ischemic stroke or transient ischemic attack (TIA), including amaurosis fugax, occurring within the last 2 weeks.
  • Initial evaluation of CT and/or CT angiography and/or MRI supports a diagnosis of TIA or ischemic stroke.
  • Available smartphone and access to the ECG247-app to be able to participate in the study.
  • Estimated life span of \>6 month
  • Permanent address in Norway
  • Informed Consent, Capable of giving signed informed consent or consent through proxy as described in Appendix which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the study protocol.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sørlandet sykehus HF
Coordinator of this site? Confirm its status
KristiansandNorwayRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.