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Active, Not Recruiting

NCT Number: NCT05445726

ECG Validation Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hope Research Institute

Phoenix, Arizona, 85018, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CPM Device

Device

CPM device used in tangent with reference ECG for validation

Primary outcomes

  1. Sensitivity

    Time frame: Baseline

    Test device AFIB detection vs reference device

  2. Specificity

    Time frame: Baseline

    Test device NSR detection vs reference device

Secondary outcomes

  1. Clinical equivalence

    Time frame: Baseline

    Test device ECG strip vs reference device

Sponsors and collaborators

Lead sponsor

Analog Device, Inc.

Other

Collaborators

  • Hope Research Institute

Registry information

Official study title

Clinical Validation Study for Noninvasive Cardiopulmonary Management Device

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jul 6, 2022
Registry last updated
Oct 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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