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Evaluation of the Detection of Atrial Fibrillation by a Wearable Dynamic ECG Recorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04462653
Recruitment Status : Recruiting
First Posted : July 8, 2020
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
Ruogu.li, Shanghai Chest Hospital

Brief Summary:

A Randomized, Crossover Trial is conducted to Evaluate Consistency Atrial fibrillation diagnosis between the Wearable Dynamic ECG Recorder and the Control device.

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: Wearable Dynamic ECG Recorder Device: 12-lead ECG recordings Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 114 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of the Consistency Between the Detection of Atrial Fibrillation by a Wearable Dynamic ECG Recorder and a Control Instrument
Actual Study Start Date : April 24, 2020
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Device: Wearable Dynamic ECG Recorder
use a Wearable Dynamic ECG Recorder to record heart rate and atrial fibrillation

Device: 12-lead ECG recordings
use a 12-lead ECG recordings to record heart rate and atrial fibrillation




Primary Outcome Measures :
  1. Consistent rate of atrial fibrillation diagnosis [ Time Frame: second 60 ]

    Electrical signals from ECG electrodes are collected with tested device and gold standard device. An automatic diagnosis of atrial fibrillation made with the tested device, and diagnosis of atrial fibrillation is made by the investigators with gold standard device. Diagnosis results include: "with atrial fibrillation (AF)", "without atrial fibrillation (No AF)", or "indecipherable".

    After the diagnosis, the number of "with atrial fibrillation (AF)", "without atrial fibrillation (No AF)", or "indecipherable" cases measured by the two devices are calculated according to table 1, and then the results are evaluated for 3×3 matching consistency.



Secondary Outcome Measures :
  1. Sensitivity and specificity of the ECG App algorithm in detecting atrial fibrillation [ Time Frame: second 60 ]
    Sensitivity and specificity of the ECG App algorithm in detecting atrial fibrillation compared with physician-adjudicated Gold Standard ECG recorder. Per the protocol, only readable and classifiable (classifiable analysis set) paired recordings are included in the diagnostic performance assessment.

  2. waveform qualitative assessment 1 [ Time Frame: second 60 ]
    1)The proportion of paired ECG strips appear to overlay to the unaided eye > 0.80.

  3. waveform qualitative assessment 2 [ Time Frame: second 60 ]
    2)The proportion of paired R-wave amplitude measurements within 2 mm of each other > 0.80


Other Outcome Measures:
  1. Safety measures 1 [ Time Frame: second 60 ]
    1.Scoring system for skin reaction:No erythema, score 0; Very slight erythema (barely perceptible), score 1; Well-defined erythema, score2;Moderate erythema, score 3;Severe erythema (beet-redness) to eschar formation preventing grading of erythema, score 4.

  2. Safety measures 2 [ Time Frame: second 60 ]
    2. Adverse event (AE)

  3. Safety measures 3 [ Time Frame: second 60 ]
    3. Equipment defector failure for example: unable to wear, no results output, signal interruption.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • - All study participants must be able to provide written informed consent prior to study procedure. This study has 2 Phases.

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:

  • • < 18 years old

    • 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04462653


Contacts
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Contact: Ruogu li, MD 86-013916139778 Pengyimin1977@163.com

Locations
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China
Shanghai Chest hospital Recruiting
Shanghai, China
Contact: Ruogu Li, MD    86-013916139778    Pengyimin1977@163.com   
Sponsors and Collaborators
Huami Corporation
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Responsible Party: Ruogu.li, Chief Physician, Shanghai Chest Hospital
ClinicalTrials.gov Identifier: NCT04462653    
Other Study ID Numbers: BZYL-5-1
First Posted: July 8, 2020    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes