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

Huami

Status: Unknown

Conditions: Atrial Fibrillation

Treatments: Device: Wearable Dynamic ECG Recorder; Device: 12-lead ECG recordings

Study type: Interventional

Funder types: Industry

Identifiers

NCT04462653

BZYL-5-1

Details and patient eligibility

About

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.

Enrollment: 114 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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114 participants in 1 patient group

use two kinds of device successively

Experimental group

Description:

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

Treatment:

Device: Wearable Dynamic ECG Recorder

Device: 12-lead ECG recordings