ECG Validation Study

  • days left to enroll
  • participants needed
  • sponsor
    Analog Device, Inc.
Updated on 4 October 2022


Subjects will be recruited and begin the study as they are identified and consent to the study. Recruiting can end when 140 subjects have initiated the study. The study does allow for additional subjects to be recruited if resources allow, leading to approximately 160 subjects. At the approximate midpoint of the study, intermediate data analysis will be performed. Enrollment will continue while this occurs. Upon arrival to the clinic on the day of the study visit, prior to the application of the reference and test devices, skin inspection of the application site will be conducted. The reference ECG device will be applied, and two initial ECGs will be taken. The precordial leads from the reference device will then be removed from the patient and the CPM Device will be applied to the participant's chest as described in the IFU materials supplied with the device (the study team will also have received training on the proper placement of the device prior to the initiation of the study). This device will be worn for the remainder of the clinic visit. On the CRF, the time that the CPM Device is placed on the chest will be denoted. The reference device and the test device will then take 2 additional ECG measurements simultaneously. During ECG measurements involving CPM device, it will be helpful to maintain silence during the entire measurement duration, as it helps the device to gather heart sounds signals without interference. The ECG results will be analyzed by certified medical personnel, where they will be asked to annotate various parameters of the ECGs. The certified medical personnel will then be asked to classify the ECGs and about the strips' clinical usability.

Condition Atrial Fibrillation
Treatment CPM Device
Clinical Study IdentifierNCT05445726
SponsorAnalog Device, Inc.
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

Able to provide written, informed consent
Individuals 18 years of age and older
Willing and able to participate in the study procedures
If in AF cohort: subjects must have a known diagnosis of AF

Exclusion Criteria

Known allergy or sensitivity to ECG electrodes or any other silicone-based electrodes
Injury or skin disturbance in the area of the test device or reference device
Acute myocardial infarction within 90 days of screening or other cardiovascular diseases that increases subject risk or renders data uninterpretable (by discretion of the investigator)
Stroke or TIA within 90 days of screening
Significant tremor that prevents subject from being still
History of abnormal life-threatening arrhythmias (by discretion of the investigator)
Pregnant (method of assessment at study physician's discretion)
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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