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COMPLETED
NCT05355948
NA

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

Sponsor: Yonsei University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1000

Start Date

2022-05-09

Completion Date

2024-07-31

Last Updated

2026-07-01

Healthy Volunteers

No

Interventions

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.

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.

Locations (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea