ECG Validation Study

Running, not enrolling · Phase 2

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID: NCT05445726
Run by: Analog Device, Inc.
People needed: 141
Starts: 2022-05-19
Expected to finish: 2023-11-01
Last updated by the study team: 2023-10-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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)

Where it is running

Hope Research Institute — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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