ECG Validation Study

Clinical Validation Study for Noninvasive Cardiopulmonary Management Device

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: CPM Device

• Study Type: Interventional
• Enrollment (Actual): 141
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85018
      • Hope Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Study Population

The study will include two cohorts: a population of subjects with a known diagnosis of AF and in AF, and a population of subjects not in AF. The goal is to recruit a participant population with a range of body types and BMIs and a goal of having women represent >30% of subjects

The minimum sample size for this study is 140 subjects (70 for AF group and 70 for non-AF group) who will all complete the entirety of exercises described in the study protocol. The study will continue recruitment past 140 subjects to enroll approximately 160 subjects if resources allow.

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Healthy; 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; CPM device used in tangent with reference ECG for validation
Active Comparator: Atrial Fibrillation Diagnosis; 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; CPM device used in tangent with reference ECG for validation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity	Test device AFIB detection vs reference device	Baseline
Specificity	Test device NSR detection vs reference device	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical equivalence	Test device ECG strip vs reference device	Baseline

Collaborators and Investigators

• Sponsor: Analog Device, Inc.
• Collaborators: Hope Research Institute
• Investigators: Principal Investigator: Matthew Doust, MD, Hope Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2022
• Primary Completion (Actual): September 2, 2022
• Study Completion (Estimated): November 1, 2023

Study Registration Dates

• First Submitted: June 30, 2022
• First Submitted That Met QC Criteria: June 30, 2022
• First Posted (Actual): July 6, 2022

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 124-332-2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes