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

Evaluation of the Consistency Between the Detection of Atrial Fibrillation by a Wearable Dynamic ECG Recorder and a Control Instrument

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.

Study Overview

• Status: Unknown
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Wearable Dynamic ECG Recorder; Device: 12-lead ECG recordings

• Study Type: Interventional
• Enrollment (Anticipated): 114
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ruogu Li, MD; Phone Number: 86-013916139778; Email: Pengyimin1977@163.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Shanghai Chest Hospital
    • Contact: Ruogu Li, MD; Phone Number: 86-013916139778; Email: Pengyimin1977@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	second 60

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	second 60
waveform qualitative assessment 1	1)The proportion of paired ECG strips appear to overlay to the unaided eye > 0.80.	second 60
waveform qualitative assessment 2	2)The proportion of paired R-wave amplitude measurements within 2 mm of each other > 0.80	second 60

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety measures 1	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.	second 60
Safety measures 2	2. Adverse event (AE)	second 60
Safety measures 3	3. Equipment defector failure for example: unable to wear, no results output, signal interruption.	second 60

Collaborators and Investigators

• Sponsor: Huami Corporation

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2020
• Primary Completion (Anticipated): August 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: May 6, 2020
• First Submitted That Met QC Criteria: July 5, 2020
• First Posted (Actual): July 8, 2020

Study Record Updates

• Last Update Posted (Actual): July 8, 2020
• Last Update Submitted That Met QC Criteria: July 5, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: BZYL-5-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No