ECG Validation Study
Primary Purpose
Atrial Fibrillation
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CPM Device
Sponsored by
About this trial
This is an interventional diagnostic trial for Atrial Fibrillation
Eligibility Criteria
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)
Sites / Locations
- Hope Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Healthy
Atrial Fibrillation Diagnosis
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
Sensitivity
Test device AFIB detection vs reference device
Specificity
Test device NSR detection vs reference device
Secondary Outcome Measures
Clinical equivalence
Test device ECG strip vs reference device
Full Information
NCT ID
NCT05445726
First Posted
June 30, 2022
Last Updated
October 5, 2023
Sponsor
Analog Device, Inc.
Collaborators
Hope Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT05445726
Brief Title
ECG Validation Study
Official Title
Clinical Validation Study for Noninvasive Cardiopulmonary Management Device
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 19, 2022 (Actual)
Primary Completion Date
September 2, 2022 (Actual)
Study Completion Date
November 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Analog Device, Inc.
Collaborators
Hope Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Comparison of test device ECG to reverence device ECG.
Masking
Outcomes Assessor
Masking Description
Cardiologist that interpret ECG strips to not know which strip is from the reference device and which is from the test device.
Allocation
Non-Randomized
Enrollment
141 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Atrial Fibrillation Diagnosis
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
CPM Device
Intervention Description
CPM device used in tangent with reference ECG for validation
Primary Outcome Measure Information:
Title
Sensitivity
Description
Test device AFIB detection vs reference device
Time Frame
Baseline
Title
Specificity
Description
Test device NSR detection vs reference device
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Clinical equivalence
Description
Test device ECG strip vs reference device
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Doust, MD
Organizational Affiliation
Hope Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hope Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
12. IPD Sharing Statement
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ECG Validation Study
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