Evaluation of the Detection of Atrial Fibrillation by a Wearable Dynamic ECG Recorder
NCT ID: NCT04462653
Last Updated: 2020-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
114 participants
INTERVENTIONAL
2020-04-24
2020-09-01
Brief Summary
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In this investigation, the following indicators is also evaluated:
1. Sensitivity and specificity of the ECG App algorithm in detecting atrial fibrillation compared with physician-adjudicated Gold Standard ECG recorder.
2. Waveform qualitative assessment
3. Safety incident assessments. 114 subjects (60 healthy subjects in phase I and 54 subjects with atrial fibrillation diagnosis in phase II) are enrolled in the investigation according to the criteria.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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use two kinds of device successively
the same participant use a Wearable Dynamic ECG Recorder and 12-lead ECG to record heart rate and atrial fibrillation
Wearable Dynamic ECG Recorder
use a Wearable Dynamic ECG Recorder to record heart rate and atrial fibrillation
12-lead ECG recordings
use a 12-lead ECG recordings to record heart rate and atrial fibrillation
Interventions
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Wearable Dynamic ECG Recorder
use a Wearable Dynamic ECG Recorder to record heart rate and atrial fibrillation
12-lead ECG recordings
use a 12-lead ECG recordings to record heart rate and atrial fibrillation
Eligibility Criteria
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Inclusion Criteria
Phase 1:
* Health conscious individuals
* \> 18 years of age
Phase 2:
* \> 18 years of age
* non critical patients ever diagnosed with atrial fibrillation
Exclusion Criteria
* Unable to consent
Phase 1:
* \> 80 years of age
* Previous history of cardiac disease (e.g., atrial fibrillation, myocardial infarction, congestive heart failure)
* current status of non-sinus heart rhythm
Phase 2:
\- Critical patients
18 Years
80 Years
ALL
Yes
Sponsors
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Huami Corporation
INDUSTRY
Responsible Party
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Ruogu.li
Chief Physician
Locations
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Shanghai Chest hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BZYL-5-1
Identifier Type: -
Identifier Source: org_study_id
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