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

Not Applicable

• Conditions: Atrial Fibrillation
• Interventions: Device: Wearable Dynamic ECG Recorder; Device: 12-lead ECG recordings

• Registration Number: NCT04462653
• Lead Sponsor: Huami Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-24
• Study First Submitted: 2020-05-06
• Status Verified: 2020-07
• Study First Submitted QC: 2020-07-05
• Last Update Submitted: 2020-07-05
• Study First Posted: 2020-07-08
• Last Update Posted: 2020-07-08
• Primary Completion: 2020-08-01
• Study Completion: 2020-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 114

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
use two kinds of device successively	Wearable Dynamic ECG Recorder	the same participant use a Wearable Dynamic ECG Recorder and 12-lead ECG to record heart rate and atrial fibrillation
use two kinds of device successively	12-lead ECG recordings	the same participant use a Wearable Dynamic ECG Recorder and 12-lead ECG to record heart rate and atrial fibrillation

Primary Outcome Measures

Name	Time	Method
Consistent rate of atrial fibrillation diagnosis	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

Name	Time	Method
Sensitivity and specificity of the ECG App algorithm in detecting atrial fibrillation	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.
waveform qualitative assessment 1	second 60	1)The proportion of paired ECG strips appear to overlay to the unaided eye \> 0.80.
waveform qualitative assessment 2	second 60	2)The proportion of paired R-wave amplitude measurements within 2 mm of each other \> 0.80

Trial Locations

Locations (1)

Shanghai Chest hospital; 🇨🇳 Shanghai, China