Evaluation of the Detection of Atrial Fibrillation by a Wearable Dynamic ECG Recorder
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|ClinicalTrials.gov Identifier: NCT04462653|
Recruitment Status : Recruiting
First Posted : July 8, 2020
Last Update Posted : July 8, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Device: Wearable Dynamic ECG Recorder Device: 12-lead ECG recordings||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||114 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Evaluation of the Consistency Between the Detection of Atrial Fibrillation by a Wearable Dynamic ECG Recorder and a Control Instrument|
|Actual Study Start Date :||April 24, 2020|
|Estimated Primary Completion Date :||August 1, 2020|
|Estimated Study Completion Date :||September 1, 2020|
Experimental: use two kinds of device successively
the same participant use a Wearable Dynamic ECG Recorder and 12-lead ECG to record heart rate and atrial fibrillation
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
- 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.
- Sensitivity and specificity of the ECG App algorithm in detecting atrial fibrillation [ Time Frame: second 60 ]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.
- waveform qualitative assessment 1 [ Time Frame: second 60 ]1)The proportion of paired ECG strips appear to overlay to the unaided eye > 0.80.
- waveform qualitative assessment 2 [ Time Frame: second 60 ]2)The proportion of paired R-wave amplitude measurements within 2 mm of each other > 0.80
- Safety measures 1 [ Time Frame: second 60 ]1.Scoring system for skin reaction:No erythema, score 0; Very slight erythema (barely perceptible), score 1; Well-defined erythema, score2;Moderate erythema, score 3;Severe erythema (beet-redness) to eschar formation preventing grading of erythema, score 4.
- Safety measures 2 [ Time Frame: second 60 ]2. Adverse event (AE)
- Safety measures 3 [ Time Frame: second 60 ]3. Equipment defector failure for example: unable to wear, no results output, signal interruption.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04462653
|Contact: Ruogu li, MD||86-013916139778||Pengyimin1977@163.com|
|Shanghai Chest hospital||Recruiting|
|Contact: Ruogu Li, MD 86-013916139778 Pengyimin1977@163.com|