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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04462653
• Other study ID #: BZYL-5-1
• Status: Recruiting
• Phase: N/A
• Start date: April 24, 2020
• Est. completion date: September 1, 2020

Study information

• Verified date: July 2020
• Source: Huami Corporation
• Contact: Ruogu li, MD
• Phone: 86-013916139778
• Email: Pengyimin1977[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 114
• Est. completion date: September 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• 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

Locations

Country	Name	City	State
China	Shanghai Chest hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huami Corporation

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Safety measures 2	2. Adverse event (AE)	second 60
Other	Safety measures 3	3. Equipment defector failure for example: unable to wear, no results output, signal interruption.	second 60
Primary	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	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
Secondary	waveform qualitative assessment 1	1)The proportion of paired ECG strips appear to overlay to the unaided eye > 0.80.	second 60
Secondary	waveform qualitative assessment 2	2)The proportion of paired R-wave amplitude measurements within 2 mm of each other > 0.80	second 60