A Clinical Trial to Evaluate the Detection of Atrial Fibrillation for an One Day Versus More Than… (NCT05355948) | Clinical Trial Compass
CompletedNot Applicable
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
South Korea1,000 participantsStarted 2022-05-09
Plain-language summary
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.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Has had prior history of Atrial fibrillation or Atrial flutter
. Has received prior or ongoing anticoagulant or antiplatelet therapy
. 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.