search
Back to results

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

Primary Purpose

Atrial Fibrillation

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Wearable Dynamic ECG Recorder
12-lead ECG recordings
Sponsored by
Huami Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Atrial Fibrillation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Shanghai Chest hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

use two kinds of device successively

Arm Description

the same participant use a Wearable Dynamic ECG Recorder and 12-lead ECG to record heart rate and atrial fibrillation

Outcomes

Primary Outcome Measures

Consistent rate of atrial fibrillation diagnosis
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

Sensitivity and specificity of the ECG App algorithm in detecting atrial fibrillation
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.
waveform qualitative assessment 1
1)The proportion of paired ECG strips appear to overlay to the unaided eye > 0.80.
waveform qualitative assessment 2
2)The proportion of paired R-wave amplitude measurements within 2 mm of each other > 0.80

Full Information

First Posted
May 6, 2020
Last Updated
July 5, 2020
Sponsor
Huami Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT04462653
Brief Title
Evaluation of the Detection of Atrial Fibrillation by a Wearable Dynamic ECG Recorder
Official Title
Evaluation of the Consistency Between the Detection of Atrial Fibrillation by a Wearable Dynamic ECG Recorder and a Control Instrument
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 24, 2020 (Actual)
Primary Completion Date
August 1, 2020 (Anticipated)
Study Completion Date
September 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huami Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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: Sensitivity and specificity of the ECG App algorithm in detecting atrial fibrillation compared with physician-adjudicated Gold Standard ECG recorder. Waveform qualitative assessment 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
114 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
use two kinds of device successively
Arm Type
Experimental
Arm Description
the same participant use a Wearable Dynamic ECG Recorder and 12-lead ECG to record heart rate and atrial fibrillation
Intervention Type
Device
Intervention Name(s)
Wearable Dynamic ECG Recorder
Intervention Description
use a Wearable Dynamic ECG Recorder to record heart rate and atrial fibrillation
Intervention Type
Device
Intervention Name(s)
12-lead ECG recordings
Intervention Description
use a 12-lead ECG recordings to record heart rate and atrial fibrillation
Primary Outcome Measure Information:
Title
Consistent rate of atrial fibrillation diagnosis
Description
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.
Time Frame
second 60
Secondary Outcome Measure Information:
Title
Sensitivity and specificity of the ECG App algorithm in detecting atrial fibrillation
Description
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.
Time Frame
second 60
Title
waveform qualitative assessment 1
Description
1)The proportion of paired ECG strips appear to overlay to the unaided eye > 0.80.
Time Frame
second 60
Title
waveform qualitative assessment 2
Description
2)The proportion of paired R-wave amplitude measurements within 2 mm of each other > 0.80
Time Frame
second 60
Other Pre-specified Outcome Measures:
Title
Safety measures 1
Description
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.
Time Frame
second 60
Title
Safety measures 2
Description
2. Adverse event (AE)
Time Frame
second 60
Title
Safety measures 3
Description
3. Equipment defector failure for example: unable to wear, no results output, signal interruption.
Time Frame
second 60

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruogu li, MD
Phone
86-013916139778
Email
Pengyimin1977@163.com
Facility Information:
Facility Name
Shanghai Chest hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruogu Li, MD
Phone
86-013916139778
Email
Pengyimin1977@163.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs