Skip to main content
OpenTrials
Completed

NCT Number: NCT05355948

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atrial Fibrillation/Flutter in Patients With High Risk of Stroke Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

[Inclusion criteria]

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

  • Has provided documented informed consent for the study.
  • Is adult at least 19 years of age on the day of providing documented informed consent
  • Is the high risk group for stroke, i.e. adult at least 75 years of age or CHA2DS2-VASc score more than 2
  • Is life expectancy more than 6 months
  • Has no Atrial fibrillation or Atrial flutter as a result of 12-lead ECG
  • 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:

  • Has had prior history of Atrial fibrillation or Atrial flutter
  • Has inserted Pacemaker or Defibrillator that can diagnose Atrial fibrillation or Atrial flutter
  • 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.

Treatment and study plan

MEMO Patch PLUS for 1 day

Device

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.

MEMO Patch PLUS for More than 8-days

Device

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.

Primary outcomes

  1. Incidence of newly diagnosed AF

    Time frame: 1 month(+1month)

    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. Incidence of newly diagnosed AF

    Time frame: 2 month(±Month 2)

    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.

Secondary outcomes

  1. Time to the first occurrence of atrial fibrillation/flutter lasting more than 30 seconds after MEMO Patch PLUS is attached.

    Time frame: 1month(+1month), 12 month(±Month 2)

  2. Adaptation rate of anticoagulant or antiplatelet therapy when atrial fibrillation/flutter is diagnosed.

    Time frame: 1month(+1month), 12 month(±Month 2)

  3. Time required to use or switch to anticoagulant or antiplatelet therapy after atrial fibrillation/flutter diagnosis.

    Time frame: 1month(+1month), 12 month(±Month 2)

  4. Burden of total atrial fibrillation/flutter occurrence time

    Time frame: 1month(+1month), 12 month(±Month 2)

  5. Incidence of significant medical events or death due to ischemic stroke/transient ischemic attack, systemic embolism, hemorrhagic stroke, atrial fibrillation/flutter.

    Time frame: 1month(+1month), 12 month(±Month 2)

  6. Percentage of arrhythmias including atrial fibrillation/flutter were detected and surgery/procedure was performed for therapeutic or diagnostic purposes.

    Time frame: 1month(+1month), 12 month(±Month 2)

  7. Distribution rate of wearing period of ECG monitoring group for more than 8 days.

    Time frame: 1month(+1month), 12 month(±Month 2)

  8. Detection rate of other arrhythmias* except atrial fibrillation/flutter.

    Time frame: 1month(+1month), 12 month(±Month 2)

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Acronym: MEMO-DAF8

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
May 2, 2022
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.