The Southern-Norway Post-Stroke Atrial Fibrillation Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Norway
Sørlandet Sykehus HF
RECRUITING
Kristiansand
Contact Information
Primary
Halvor Oeygarden, PhD
halvor.oygarden@sshf.no
+4747621336
Backup
Ivana Sapina, PhD student
ivana.sapina@sshf.no
+47 47311701
Time Frame
Start Date: 2026-01-10
Estimated Completion Date: 2029-12
Participants
Target number of participants: 450
Treatments
Experimental: Intervention Arm (ECG247 Smart Heart Sensor)
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.
Other: Control Arm (Standard Care)
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.
Related Therapeutic Areas
Sponsors
Leads: Sorlandet Hospital HF

This content was sourced from clinicaltrials.gov