NCT05445726

ECG Validation Study

Clinical Validation Study for Noninvasive Cardiopulmonary Management Device

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 141 (actual)
• Sponsor: Analog Device, Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	CPM Device	CPM device used in tangent with reference ECG for validation

Timeline

• Start date: 2022-05-19
• Primary completion: 2022-09-02
• Completion: 2023-11-01
• First posted: 2022-07-06
• Last updated: 2023-10-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study