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

NCT04462653 | Unknown

• 1 other identifier: BZYL-5-1
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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. 1.Sensitivity and specificity of the ECG App algorithm in detecting atrial fibrillation compared with physician-adjudicated Gold Standard ECG recorder.
2. 2.Waveform qualitative assessment
3. 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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Sensitivity and specificity of the ECG App algorithm in detecting atrial fibrillation

  second 60

• waveform qualitative assessment 1

  second 60

• waveform qualitative assessment 2

  second 60

Other Outcomes (3)

• Safety measures 1

  second 60

• Safety measures 2

  second 60

• Safety measures 3

  second 60

Study Arms (1)

use two kinds of device successively

EXPERIMENTAL

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; Device: 12-lead ECG recordings

Interventions

Wearable Dynamic ECG Recorder DEVICE

use a Wearable Dynamic ECG Recorder to record heart rate and atrial fibrillation

use two kinds of device successively

12-lead ECG recordings DEVICE

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

use two kinds of device successively

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• \< 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

Sponsors & Collaborators

• Huami Corporation: lead

Study Sites (1)

Shanghai Chest hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ruogu li, MD

CONTACT

86-013916139778; Pengyimin1977@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: July 8, 2020
• Study Start: April 24, 2020
• Primary Completion: August 1, 2020
• Study Completion: September 1, 2020
• Last Updated: July 8, 2020

Record last verified: 2020-07

Locations

CN (1)