A Clinical Trial to Evaluate the Detection of Atrial Fibrillation for an One Day Versus More Than or Equal to Eight Days Using MEMO Patch PLUS in Individuals Aged ≥ 75 Years, or Those at High Risk of Stroke (MEMO-DAF8)

A Prospective, Multi-Center, Randomized Clinical Trial to Evaluate the Detection of Atrial Fibrillation for an One Day Versus More Than or Equal to Eight Days Using MEMO Patch PLUS in Individuals Aged ≥ 75 Years, or Those at High Risk of Stroke: MEMO-DAF8

The purpose of this study is to evaluate the benefits in the atrial fibrillation detection rate of the continuous ECG monitoring group for more than 8 days by contrasting with one-day ECG monitoring using MEMO Patch PLUS in 1000 patients with atrial fibrillation-related symptoms in the high risk group of stroke. The participant is allocated randomly to One-day ECG monitoring group or the continuous ECG monitoring group for more than 8 days in ratio of 1:1, only if the participant provides informed consent and eligible for all the inclusion/exclusion criteria. The investigator confirms the results of MEMO Patch PLUS monitoring at 1 month from the date of MEMO Patch PLUS attachment. The participation of the subject is terminated on the 1 year from the date of MEMO Patch PLUS attachment. On that day, investigator evaluates incidence of the event associated with atrial fibrillation, the event is included ischemic stroke/transient ischemic accident, hemorrhagic stroke, systemic embolism, etc.

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation/Flutter in Patients With High Risk of Stroke
• Intervention / Treatment: Device: MEMO Patch PLUS for 1 day; Device: MEMO Patch PLUS for More than 8-days

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Yonsei University Health system, Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

[Inclusion criteria]

A participant will be eligible for inclusion in the study if the participant:

1. Has provided documented informed consent for the study.
2. Is adult at least 19 years of age on the day of providing documented informed consent
3. Is the high risk group for stroke, i.e. adult at least 75 years of age or CHA2DS2-VASc score more than 2
4. Is life expectancy more than 6 months
5. Has no Atrial fibrillation or Atrial flutter as a result of 12-lead ECG
6. Has symptoms associated with Atrial fibrillation *symptoms associated with Atrial fibrillation: palpitation, dizziness, dyspnea, syncope, stroke/transient ischemic accident, systemic embolism etc.

[Exclusion criteria]

The participant must be excluded from the study if the participant:

1. Has had prior history of Atrial fibrillation or Atrial flutter
2. Has received prior or ongoing anticoagulant or antiplatelet therapy
3. Has inserted Pacemaker or Defibrillator that can diagnose Atrial fibrillation or Atrial flutter
4. Has plan of Carotid endarterectomy or inserting Stent* within 90 days on the day of providing document informed consent *Stent insertion: means when stent-related interventions have been performed on the carotid arteyr or coronary arteries.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MEMO Patch PLUS ECG monitoring for One-day	Device: MEMO Patch PLUS for 1 day; Individuals randomized to one-day monitoring will wear MEMO Patch PLUS for 1 day. After that, confirm the monitoring result and carry out a fixed schedule.
Experimental: MEMO Patch PLUS ECG monitoring for More than 8-days	Device: MEMO Patch PLUS for More than 8-days; Individuals randomized to More than 8-days monitoring will wear MEMO Patch PLUS for 8 days ~ 14 days at their voluntarily. After that, confirm the monitoring result and carry out a fixed schedule.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of newly diagnosed AF	Incidence of newly diagnosed AF refers to a case that lasts longer than 30 seconds, which is an indication for anticoagulation or antiplatelet therapy in standard therapy.	1 month(+1month)
Incidence of newly diagnosed AF	Incidence of newly diagnosed AF refers to a case that lasts longer than 30 seconds, which is an indication for anticoagulation or antiplatelet therapy in standard therapy.	2 month(±Month 2)

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to the first occurrence of atrial fibrillation/flutter lasting more than 30 seconds after MEMO Patch PLUS is attached.	1month(+1month), 12 month(±Month 2)
Adaptation rate of anticoagulant or antiplatelet therapy when atrial fibrillation/flutter is diagnosed.	1month(+1month), 12 month(±Month 2)
Time required to use or switch to anticoagulant or antiplatelet therapy after atrial fibrillation/flutter diagnosis.	1month(+1month), 12 month(±Month 2)
Burden of total atrial fibrillation/flutter occurrence time	1month(+1month), 12 month(±Month 2)
Incidence of significant medical events or death due to ischemic stroke/transient ischemic attack, systemic embolism, hemorrhagic stroke, atrial fibrillation/flutter.	1month(+1month), 12 month(±Month 2)
Percentage of arrhythmias including atrial fibrillation/flutter were detected and surgery/procedure was performed for therapeutic or diagnostic purposes.	1month(+1month), 12 month(±Month 2)
Distribution rate of wearing period of ECG monitoring group for more than 8 days.	1month(+1month), 12 month(±Month 2)
Detection rate of other arrhythmias* except atrial fibrillation/flutter.	1month(+1month), 12 month(±Month 2)

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Boyoung Joung, Severance Cardiovascular Hospital Yonsei University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2022
• Primary Completion (Anticipated): July 31, 2023
• Study Completion (Anticipated): July 31, 2024

Study Registration Dates

• First Submitted: April 21, 2022
• First Submitted That Met QC Criteria: April 29, 2022
• First Posted (Actual): May 2, 2022

Study Record Updates

• Last Update Posted (Actual): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 29, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arrhythmias, Cardiac; Stroke; Atrial Fibrillation
• Other Study ID Numbers: 1-2022-0008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No