Atrial FibrillationNCT04462653
Evaluation of the Detection of Atrial Fibrillation by a Wearable Dynamic ECG Recorder
A study testing Wearable Dynamic ECG Recorder and 12-lead ECG recordings in people with Atrial Fibrillation, run by Huami Corporation at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Wearable Dynamic ECG Recorder and 12-lead ECG recordings
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteChina
- Study dates
- 24 Apr 2020to 1 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- - 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
Who cannot join
- • < 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest hospital
Shanghai
Ruogu Li, MD, 86-013916139778, Pengyimin1977@163.com
About this study
Official title: Evaluation of the Consistency Between the Detection of Atrial Fibrillation by a Wearable Dynamic ECG Recorder and a Control Instrument
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:
- Sensitivity and specificity of the ECG App algorithm in detecting atrial fibrillation compared with physician-adjudicated Gold Standard ECG recorder.
- Waveform qualitative assessment
- 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
- Being tested
- Wearable Dynamic ECG Recorder, 12-lead ECG recordings
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable Dynamic ECG RecorderDevice
use a Wearable Dynamic ECG Recorder to record heart rate and atrial fibrillation
12-lead ECG recordingsDevice
use a 12-lead ECG recordings to record heart rate and atrial fibrillation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Wearable Dynamic ECG Recorder; Device: 12-lead ECG recordings |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: second 60
Secondary outcomes (3)
Sensitivity and specificity of the ECG App algorithm in detecting atrial fibrillation
Sensitivity and specificity of the ECG App algorithm in detecting atrial fibrillation compared with physician-adjudicated Gold Standard ECG recorder. Per the protocol, only readable and classifiable (classifiable analysis set) paired recordings are included in the diagnostic performance assessment.
Measured: second 60
waveform qualitative assessment 1
1)The proportion of paired ECG strips appear to overlay to the unaided eye > 0.80.
Measured: second 60
waveform qualitative assessment 2
2)The proportion of paired R-wave amplitude measurements within 2 mm of each other > 0.80
Measured: second 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start24 Apr 2020
- Primary completion1 Aug 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huami Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Ruogu.li, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04462653
- Sponsor's protocol ID
- BZYL-5-1
- Status last verified
- Jul 2020
- First submitted
- 6 May 2020
- Last updated
- 8 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Consistency Between the Detection of Atrial Fibrillation by a Wearable Dynamic ECG Recorder and a Control Instrument
- ClinicalTrials.gov ID
- NCT04462653
- Acronym / sponsor ID
- BZYL-5-1
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Huami CorporationIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2020 (actual)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 8 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Sensitivity and specificity of the ECG App algorithm in detecting atrial fibrillation compared with physician-adjudicated Gold Standard ECG recorder.
- Waveform qualitative assessment
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| use two kinds of device successively | Experimental | Device: Wearable Dynamic ECG Recorder, Device: 12-lead ECG recordingsthe same participant use a Wearable Dynamic ECG Recorder and 12-lead ECG to record heart rate and atrial fibrillation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- - All study participants must be able to provide written informed consent prior to study procedure. This study has 2 Phases.
- Health conscious individuals
- > 18 years of age
- > 18 years of age
- non critical patients ever diagnosed with atrial fibrillation
Key exclusion criteria (8 listed)
- • < 18 years old
- > 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
- Critical patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable Dynamic ECG Recorderuse a Wearable Dynamic ECG Recorder to record heart rate and atrial fibrillation | Device | use two kinds of device successively |
| 12-lead ECG recordingsuse a 12-lead ECG recordings to record heart rate and atrial fibrillation | Device | use two kinds of device successively |
Primary outcome
Consistent rate of atrial fibrillation diagnosis
Time frame: second 60
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.
3 secondary outcomes
Sensitivity and specificity of the ECG App algorithm in detecting atrial fibrillation
Time frame: second 60
waveform qualitative assessment 1
Time frame: second 60
waveform qualitative assessment 2
Time frame: second 60
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable Dynamic ECG Recorder and 12-lead ECG recordings in people with Atrial Fibrillation, run by Huami Corporation at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruogu li, MD (86-013916139778, Pengyimin1977@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consistent rate of atrial fibrillation diagnosis (time frame: second 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.