The Southern-Norway Post-Stroke Atrial Fibrillation Study

NCT07407790 | Recruiting

• 1 other identifier: REKID 931942
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation (AF); Atrial Fibrillation (Prevention of Stroke); Ischemic Stroke; Secondary Prevention; Arrhythmia Atrial

Keywords

stroke; atrial fibrillation; anticoagulation

Outcome Measures

Primary Outcomes (5)

• Detection rate of atrial fibrillation

  The detection rate of AF (defined as episodes ≥30 seconds). Analysis will be performed on an intention-to-treat basis, and AF detection will be primarily assessed for its non-inferiority and secondarily for difference in proportions. An interim analysis for efficacy measures will be performed using the O'Brien-Flemming correction for the primary endpoint AF detection rate after 72 and 144 participants in each arm.

  From enrollment to the end of heart rate monitoring. Will also be registered on follow up after 12 months.

• Time from enrollment to treatment initiation with anticoagulant medicine

  Days from enrollment until AF detection results in change of prophylactic treatment, defined as prescribed anticoagulant medication collected by the patient, retrieved from e-prescription data accessed through the Summary Care Record (Kjernejournal).

  From enrollment until end of follow up (12 months after enrollment).

• Time from enrollment to detection of first AF episode

  Time to detection of first episode of atrial fibrillation after hospital admission

  From enrollment up to 1 year

• Total duration of heart rate monitoring

  Total duration of heart rate monitoring, also including an assessment of device signal quality for assessment

  From enrollment up to 1 year

• Numbers of participants with secondary stroke/TIA and/or major bleeding

  Assessing secondary stroke and major bleeding at 1 year of follow-up

  From enrollment to one-year follow up, assessed at 1-year follow up.

Secondary Outcomes (7)

• Explore the practical utility in regards to validity of results of AF screening after a stroke with a patch ECG

  After 1 year of recruitment

• Explore the practical utility of time consumed using AF screening after a stroke with a patch ECG

  After 1 year of recruitment

• Explore the practical utility and reliability of AF screening after a stroke with a patch ECG

  Assessed at 1 year after enrollment start

• Explore the practical utility and patient satisfaction of AF screening after a stroke with a patch ECG

  Through study completion

• Diagnostic quality of in-house patch ECG compared to telemetry

  From start of enrollment until discharge of last included patient

Study Arms (2)

Intervention Arm (ECG247 Smart Heart Sensor)

EXPERIMENTAL

Patients in this group will have the ECG247 patch applied to the anterior chest wall while in the hospital. * Device: The ECG247 is a wireless, water-resistant patch sensor that connects to a dedicated smartphone application via Bluetooth. It transmits data to a secure cloud service for analysis. * Duration: The device is worn continuously for up to 14 days. Monitoring begins in-hospital and continues after discharge. * Analysis: The system utilizes an algorithm to detect arrhythmia. Episodes of AF \>30 seconds are considered positive findings. Study personnel and physicians verify algorithm-detected episodes. * Concurrent Care: These patients also receive standard in-house telemetry per hospital protocol while admitted.

Device: Patch ECG

Control Arm (Standard Care)

OTHER

Patients in this group receive standard heart rhythm monitoring according to current hospital guidelines. * In-hospital: Monitoring via continuous telemetry or intermittent ECGs based on availability and clinical priority. * Ambulatory: Upon discharge, patients are referred for ambulatory Holter monitoring. The duration is typically 24-48 hours as decided by the treating cardiologist. * Analysis: Holter recordings are analyzed by trained technicians and reviewed by a cardiologist.

Device: Standard Care (in control arm)

Interventions

Patch ECG DEVICE

This study aims to evaluate the clinical utility and cost-effectiveness of a novel, continuous patch ECG system (ECG247) initiated in the hospital setting compared to standard care.

Intervention Arm (ECG247 Smart Heart Sensor)

Standard Care (in control arm) DEVICE

Patients in this group receive standard heart rhythm monitoring according to current hospital guidelines.

Control Arm (Standard Care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• Medical Conditions
• 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).
• Implanted pacemaker, ICD or loop-recorder
• \>70% stenosis of carotid artery on ipsilateral side to the stroke on CT angiography or ultrasound
• Pregnancy

Sponsors & Collaborators

• Sorlandet Hospital HF: lead

Study Sites (1)

Sørlandet Sykehus HF

Kristiansand, 4615, Norway

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Ischemic Stroke; Stroke

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Central Study Contacts

Halvor Oeygarden, PhD

CONTACT

+4747621336; halvor.oygarden@sshf.no

Ivana Sapina, PhD student

CONTACT

+47 47311701; ivana.sapina@sshf.no

Study Design

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

Model Details: This is a prospective, randomized, parallel-group, open-label (no masking) screening study.

Study Record Dates

• First Submitted: January 25, 2026
• First Posted: February 12, 2026
• Study Start: January 10, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: February 12, 2026

Record last verified: 2025-12

Locations

NO (1)