Status:

UNKNOWN

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

Lead Sponsor:

Huami Corporation

Conditions:

Atrial Fibrillation

Eligibility:

All Genders

18-80 years

Phase:

NA

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...

Eligibility Criteria

Inclusion

  • \- 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

  • • \< 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

Key Trial Info

Start Date :

April 24 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 1 2020

Estimated Enrollment :

114 Patients enrolled

Trial Details

Trial ID

NCT04462653

Start Date

April 24 2020

End Date

September 1 2020

Last Update

July 8 2020

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Shanghai Chest hospital

Shanghai, China

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