ECG Validation Study

NCT05445726 | Active Not Recruiting Phase 2 FDA Device

• 1 other identifier: 124-332-2022
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Sensitivity

  Test device AFIB detection vs reference device

  Baseline

• Specificity

  Test device NSR detection vs reference device

  Baseline

Secondary Outcomes (1)

• Clinical equivalence

  Baseline

Study Arms (2)

Healthy

ACTIVE COMPARATOR

Generally healthy participants that are able to participate in study procedures (i.e. laying down, sitting up, shaving chest hair for ECG/Test device placement if needed).

Device: CPM Device

Atrial Fibrillation Diagnosis

ACTIVE COMPARATOR

Participants with a diagnosis of atrial fibrillation that are able to participate in study procedures (i.e. laying down, sitting up, shaving chest hair for ECG/Test device placement if needed).

Device: CPM Device

Interventions

CPM Device DEVICE

CPM device used in tangent with reference ECG for validation

Atrial Fibrillation Diagnosis; Healthy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Analog Device, Inc.: lead
• Hope Research Institute: collaborator

Study Sites (1)

Hope Research Institute

Phoenix, Arizona, 85018, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthew Doust, MD

  Hope Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Cardiologist that interpret ECG strips to not know which strip is from the reference device and which is from the test device.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Comparison of test device ECG to reverence device ECG.

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: July 6, 2022
• Study Start: May 19, 2022
• Primary Completion: September 2, 2022
• Study Completion: November 1, 2023
• Last Updated: October 6, 2023

Record last verified: 2023-10

Locations

US (1)