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

NCT04462653 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2020-07-08

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Huami Corporation

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-04-24
Primary Completion
2020-08-01
Completion
2020-09-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04462653 on ClinicalTrials.gov