Back to resultsA 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)
Primary Purpose
Atrial Fibrillation/Flutter in Patients With High Risk of Stroke
Status
Not yet recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
MEMO Patch PLUS for 1 day
MEMO Patch PLUS for More than 8-days
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation/Flutter in Patients With High Risk of Stroke
Eligibility Criteria
[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 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.
Sites / Locations
- Yonsei University Health System, Severance Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
MEMO Patch PLUS ECG monitoring for One-day
MEMO Patch PLUS ECG monitoring for More than 8-days
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Time to the first occurrence of atrial fibrillation/flutter lasting more than 30 seconds after MEMO Patch PLUS is attached.
Adaptation rate of anticoagulant or antiplatelet therapy when atrial fibrillation/flutter is diagnosed.
Time required to use or switch to anticoagulant or antiplatelet therapy after atrial fibrillation/flutter diagnosis.
Burden of total atrial fibrillation/flutter occurrence time
Incidence of significant medical events or death due to ischemic stroke/transient ischemic attack, systemic embolism, hemorrhagic stroke, atrial fibrillation/flutter.
Percentage of arrhythmias including atrial fibrillation/flutter were detected and surgery/procedure was performed for therapeutic or diagnostic purposes.
Distribution rate of wearing period of ECG monitoring group for more than 8 days.
Detection rate of other arrhythmias* except atrial fibrillation/flutter.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05355948
Brief Title
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
Acronym
MEMO-DAF8
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2022 (Anticipated)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation/Flutter in Patients With High Risk of Stroke
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MEMO Patch PLUS ECG monitoring for One-day
Arm Type
Experimental
Arm Title
MEMO Patch PLUS ECG monitoring for More than 8-days
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
MEMO Patch PLUS for 1 day
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
MEMO Patch PLUS for More than 8-days
Intervention Description
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 Outcome Measure Information:
Title
Incidence of newly diagnosed AF
Description
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.
Time Frame
1 month(+1month)
Title
Incidence of newly diagnosed AF
Description
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.
Time Frame
2 month(±Month 2)
Secondary Outcome Measure Information:
Title
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)
Title
Adaptation rate of anticoagulant or antiplatelet therapy when atrial fibrillation/flutter is diagnosed.
Time Frame
1month(+1month), 12 month(±Month 2)
Title
Time required to use or switch to anticoagulant or antiplatelet therapy after atrial fibrillation/flutter diagnosis.
Time Frame
1month(+1month), 12 month(±Month 2)
Title
Burden of total atrial fibrillation/flutter occurrence time
Time Frame
1month(+1month), 12 month(±Month 2)
Title
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)
Title
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)
Title
Distribution rate of wearing period of ECG monitoring group for more than 8 days.
Time Frame
1month(+1month), 12 month(±Month 2)
Title
Detection rate of other arrhythmias* except atrial fibrillation/flutter.
Time Frame
1month(+1month), 12 month(±Month 2)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
[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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Boyoung Joung
Phone
+82 02-2228-8447
Email
cby6908@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boyoung Joung
Organizational Affiliation
Severance Cardiovascular Hospital Yonsei University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei University Health System, Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boyoung Joung
Phone
+82 02-2228-8447
Email
cby6908@yuhs.ac
12. IPD Sharing Statement
Learn more about this trial
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
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