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| Name | Class |
|---|---|
| Hope Research Institute | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPM Device | Device | CPM device used in tangent with reference ECG for validation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity | Test device AFIB detection vs reference device | Baseline |
| Specificity | Test device NSR detection vs reference device | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical equivalence | Test device ECG strip vs reference device | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Doust, MD | Hope Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hope Research Institute | Phoenix | Arizona | 85018 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 22, 2024 | Mar 21, 2024 | 6 | ||
| May 14, 2024 |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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Comparison of test device ECG to reverence device ECG.
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Cardiologist that interpret ECG strips to not know which strip is from the reference device and which is from the test device.
| Jun 10, 2024 |
| 7 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |