Atrial Fibrillation Detection Using MEMO Patch in Patients With Stroke of Unknown Cause: A Single-Center, Prospective, Exploratory Trial to Validate the Efficacy and Safety of Noninvasive Long-Term Electrocardiographic Monitoring

What this Trial Is About

Researchers are evaluating the effectiveness and safety of a wearable device called MEMO Patch in detecting undiagnosed atrial fibrillation in patients with Embolic Stroke of Undetermined Source (ESUS) who need screening for this heart rhythm condition. This prospective, single-center exploratory trial aims to compare long-term non-invasive ECG monitoring using MEMO Patch devices with standard Holter monitoring and implantable loop recorders (ILR) to identify atrial fibrillation in 100 patients. During hospitalization, participants will wear MEMO Patch M, a single-lead ECG patch, for between 12 hours and 8 days while also undergoing 24-hour Holter monitoring. Before discharge, results from both monitors will be reviewed to decide if an ILR is needed. After discharge, all participants will wear MEMO Patch2 for up to 14 days for their first outpatient monitoring period. One month after discharge, they will have a second 14-day monitoring period with MEMO Patch2. The study concludes with a review of the second monitoring results three months after discharge. Participants will provide informed consent and undergo interviews and medical record reviews before enrollment. Throughout the study, researchers will collect data from the wearable ECG devices, Holter monitors, and clinical assessments to detect atrial fibrillation and other arrhythmias. The main outcome is the detection rate of atrial fibrillation during hospitalization, with additional measures recorded during outpatient monitoring. The total participation lasts about three months following discharge, with careful review of monitoring results guiding treatment decisions and safety assessments.

Atrial Fibrillation Detection Using MEMO Patch in Patients With Stroke of Unknown Cause