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 range19 Years
SexALL
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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
✕. 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.