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Recruiting NCT07407790

NCT07407790 The Southern-Norway Post-Stroke Atrial Fibrillation Study

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Clinical Trial Summary
NCT ID NCT07407790
Status Recruiting
Phase
Sponsor Sorlandet Hospital HF
Condition Atrial Fibrillation (AF)
Study Type INTERVENTIONAL
Enrollment 450 participants
Start Date 2026-01-10
Primary Completion 2028-12

Trial Parameters

Condition Atrial Fibrillation (AF)
Sponsor Sorlandet Hospital HF
Study Type INTERVENTIONAL
Phase N/A
Enrollment 450
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2026-01-10
Completion 2028-12
Interventions
Patch ECGStandard Care (in control arm)

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Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * 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. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: Medical Conditions * 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,

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: April 2026  ·  Data Methodology