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NCT04462653

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

Status unknown NA Last updated 8 July 2020
What this trial tests

NA trial testing Wearable Dynamic ECG Recorder in Atrial Fibrillation in 114 participants. Status unknown.

Timeline
24 April 2020
Primary endpoint
1 August 2020
1 September 2020

Quick facts

Lead sponsorHuami Corporation
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposesupportive care
Enrollment114
Start date24 April 2020
Primary completion1 August 2020
Estimated completion1 September 2020
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Huami Corporation

Who can join

Adults 18 to 80, any sex, with Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Atrial Fibrillation

Currently open trials in the same condition.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04462653.

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