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

Official title

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

Overview

The purpose of this study is to evaluate the efficacy and safety of a wearable device in detecting previously undiagnosed atrial fibrillation through non-invasive long-term monitoring using a wearable single-lead ECG patch (MEMO Patch M, MEMO Patch2) in 100 patients with Embolic Stroke of Undetermined Source (ESUS) who require atrial fibrillation screening. Participants who meet all inclusion and exclusion criteria and provide written informed consent will wear the MEMO Patch M and undergo in-hospital telemetry monitoring using MEMO Cue for a minimum of 12 hours and up to 8 days. During hospitalization, 24-hour Holter monitoring will also be conducted. Before discharge, the investigator will review these results to determine whether implantable loop recorder (ILR) implantation is necessary. At the time of discharge, participants will wear MEMO Patch2 for up to 14 days for the first ECG monitoring period. One month after discharge, the investigator will review the results of the first monitoring and initiate the second ECG monitoring with MEMO Patch2. Three months after discharge, the results of the second ECG monitoring will be reviewed, and participation in the clinical trial will be completed.

Detailed description

This clinical study is designed as a prospective, single-center, investigator-initiated exploratory clinical trial.

1. Screening Participants will be assigned a screening number in the order in which informed consent is obtained. Through interviews and review of previous medical records, demographic information, medical history, surgical/procedural history, prior medications, and other required assessment items will be collected. Eligibility for study participation will be determined by reviewing the inclusion and exclusion criteria. 2. Visit 1 (In-Hospital Telemetry Monitoring) Eligible participants will be fitted with the investigational medical device, MEMO Patch M, and will undergo in-hospital telemetry monitoring using MEMO Cue for a minimum of 12 hours and up to 8 days. A 24-hour Holter monitor will also be applied after admission. Prior to discharge, participants will review the MEMO Patch M (in-hospital telemetry) results to determine whether ILR implantation is required. 3. Discharge (First ECG Monitoring) At discharge, participants who were not detected with atrial fibrillation using the Holter ECG or MEMO Patch M will receive an Implantable Loop Recorder (ILR). Participants in whom atrial fibrillation is detected will not receive ILR implantation. Regardless of ILR implantation, all participants will wear MEMO Patch2 and undergo additional ECG monitoring for up to 14 days after discharge. After the scheduled monitoring period ends, MEMO Patch2 will be returned using the Huinno courier service. 4. Visit 2 (Review of First ECG Monitoring Results - 1-Month Visit) At the 1-month outpatient visit, participants will review the results of the first ECG monitoring. They will then undergo a second monitoring period by wearing MEMO Patch2 for up to 14 days. After completing the scheduled monitoring period, MEMO Patch2 will be returned using the Huinno courier service. 5. Visit 3 (Review of Second ECG Monitoring Results - 3-Month Visit) At the 3-month outpatient visit, participants will review the results of the second ECG monitoring. After this visit, participation in the clinical study will be completed.

Interventions

• Device MEMO Patch M and MEMO Patch2
  During hospitalization, participants will wear MEMO Patch M, a single-lead wearable ECG patch, for 12 hours to up to 8 days. A 24-hour Holter monitor will also be performed during hospitalization. Before discharge, investigators will review the MEMO Patch M and Holter results to assess the need for implantable loop recorder (ILR) implantation. At the time of discharge, participants will wear MEMO Patch2 for up to 14 days for the first ECG monitoring period. One month after discharge, participant

Primary outcome measures

• Detection rate of Atrial Fibrillation (%) [Time frame: During V1 (Day 0 to Day 8)]

Secondary outcome measures (8)

• Time of Atrial Fibrillation (AF) detection [Time frame: 30 days (+7 days) and 90 days (+7 days) post-discharge (discharge = up to Day 8)]
• Accuracy of in-hospital monitoring alarms [Time frame: During V1 (Day 0 to Day 8)]
• AF detection rate and burden during out-of-hospital MEMO Patch2 monitoring [Time frame: 30 days (+7 days) and 90 days (+7 days) post-discharge (discharge = up to Day 8)]
• Detection rate of non-AF arrhythmias [Time frame: During V1 (Day 0-8), 30 days (+7 days) and 90 days (+7 days) post-discharge (discharge = up to Day 8)]
• Analysis of arrhythmia types including AF [Time frame: During V1 (Day 0-8), 30 days (+7 days) and 90 days (+7 days) post-discharge (discharge = up to Day 8)]
• Risk factor analysis for AF occurrence [Time frame: Screening (Day-28 to Day 0), 30 days (+7 days) and 90 days (+7 days) post-discharge (discharge = up to Day 8)]
• Rate and timing of treatment strategy changes (Including medication and procedures) after AF diagnosis [Time frame: During V1 (Day 0-8), 30 days (+7 days) and 90 days (+7 days) post-discharge (discharge = up to Day 8)]
• Comparison of AF detection rates and timing between two monitoring strategies (MEMO Patch M + MEMO Patch2 vs. Holter + ILR) [Time frame: During V1 (Day 0-8), 30 days (+7 days) and 90 days (+7 days) post-discharge (discharge = up to Day 8)]

Eligibility criteria

Inclusion criteria

Participants may take part in this clinical study only if they meet all of the following criteria:

• Adults aged 19 years or older who voluntarily provide written informed consent to participate in the study
• Patients diagnosed with ESUS (Embolic Stroke of Undetermined Source)
• Patients who require in-hospital or out-of-hospital electrocardiographic (ECG) monitoring

Exclusion criteria

Participants who meet any of the following criteria cannot be enrolled in this clinical study:

• Individuals already diagnosed with atrial fibrillation or atrial flutter
• Individuals with a clearly identified cause of stroke
• Individuals known to have allergic reactions to adhesives or hydrogels
• Individuals who, in the investigator's judgment, have cognitive vulnerability that makes it difficult to understand the study information and voluntarily decide on participation
• Any other individuals whom the principal investigator considers to be at potential risk by participating in the study or otherwise unsuitable for participation

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

South Korea · 1 center

• Asan Medical Center — Seoul

Publications

• Lumikari TJ, Putaala J, Kerola A, Sibolt G, Pirinen J, Pakarinen S, Lehto M, Nieminen T. Continuous 4-week ECG monitoring with adhesive electrodes reveals AF in patients with recent embolic stroke of undetermined source. Ann Noninvasive Electrocardiol. 2019 Sep;24(5):e12649. doi: 10.1111/anec.12649. Epub 2019 May 2. PMID 31045315
• Gladstone DJ, Spring M, Dorian P, Panzov V, Thorpe KE, Hall J, Vaid H, O'Donnell M, Laupacis A, Cote R, Sharma M, Blakely JA, Shuaib A, Hachinski V, Coutts SB, Sahlas DJ, Teal P, Yip S, Spence JD, Buck B, Verreault S, Casaubon LK, Penn A, Selchen D, Jin A, Howse D, Mehdiratta M, Boyle K, Aviv R, Kapral MK, Mamdani M; EMBRACE Investigators and Coordinators. Atrial fibrillation in patients with cryp PMID 24963566
• Sanna T, Diener HC, Passman RS, Di Lazzaro V, Bernstein RA, Morillo CA, Rymer MM, Thijs V, Rogers T, Beckers F, Lindborg K, Brachmann J; CRYSTAL AF Investigators. Cryptogenic stroke and underlying atrial fibrillation. N Engl J Med. 2014 Jun 26;370(26):2478-86. doi: 10.1056/NEJMoa1313600. PMID 24963567
• Kulach A, Dewerenda M, Majewski M, Lasek-Bal A, Gasior Z. 72 hour Holter monitoring, 7 day Holter monitoring, and 30 day intermittent patient-activated heart rhythm recording in detecting arrhythmias in cryptogenic stroke patients free from arrhythmia in a screening 24 h Holter. Open Med (Wars). 2020 Jul 18;15(1):697-701. doi: 10.1515/med-2020-0203. eCollection 2020. PMID 33336026
• Ramos-Maqueda J, Navarro-Valverde C, Esteve-Ruiz I, Cabrera-Ramos M, Rivera-Lopez R, Garcia-Medina D, Pavon-Jimenez R, Molano-Casimiro FJ. Atrial fibrillation predictors in patients with embolic stroke of undetermined source. Med Clin (Barc). 2021 Dec 24;157(12):555-560. doi: 10.1016/j.medcli.2020.09.024. Epub 2021 Jan 29. English, Spanish. PMID 33518373
• Miyazaki Y, Toyoda K, Iguchi Y, Hirano T, Metoki N, Tomoda M, Shiozawa M, Koge J, Okada Y, Terasawa Y, Kikuno M, Okano H, Hagii J, Nakajima M, Komatsu T, Yasaka M. Atrial Fibrillation After Ischemic Stroke Detected by Chest Strap-Style 7-Day Holter Monitoring and the Risk Predictors: EDUCATE-ESUS. J Atheroscler Thromb. 2021 May 1;28(5):544-554. doi: 10.5551/jat.58420. Epub 2020 Aug 15. PMID 32801289
• Hart RG, Catanese L, Perera KS, Ntaios G, Connolly SJ. Embolic Stroke of Undetermined Source: A Systematic Review and Clinical Update. Stroke. 2017 Apr;48(4):867-872. doi: 10.1161/STROKEAHA.116.016414. Epub 2017 Mar 6. PMID 28265016
• Kleindorfer DO, Towfighi A, Chaturvedi S, Cockroft KM, Gutierrez J, Lombardi-Hill D, Kamel H, Kernan WN, Kittner SJ, Leira EC, Lennon O, Meschia JF, Nguyen TN, Pollak PM, Santangeli P, Sharrief AZ, Smith SC Jr, Turan TN, Williams LS. 2021 Guideline for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack: A Guideline From the American Heart Association/American Stroke Ass PMID 34024117

Identifiers

NCT: NCT07295769 · MEMO-ESUS

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗