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Data Analysis
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The primary objective of this study is to evaluate the feasibility of a novel app to facilitate heart failure patients to acquire lung ultrasound images and evaluate the quality of those images to expert scans, and to evaluate for relationships between the ultrasound data and pulmonary pressure data from the Abbott CardioMEMS system.
Feasibility study to compare an investigational Artificial Intelligence (AI) Auto B-line tool measurement on Lung Ultrasound (US) images acquired with an AI assisted guidance tool by novice ultrasound clinicians and heart failure (HF) patients, to standard of care heart failure monitoring of pulmonary artery pressure measured by the Abbott CardioMEMS system.
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| Measure | Description | Time Frame |
|---|---|---|
| Patients Image Quality | Image quality comparisons between ultrasound scans performed by heart failure patients using the study app to traditional ultrasound scans performed by trained clinicians | Study Completion (91 days) |
| Novice Image Quality | Image quality comparisons between ultrasound scans performed by novice clinicians using the study app to traditional ultrasound scans performed by trained clinicians | Study Completion (91 days) |
| B-Line count CardioMEMS comparison | Relationship comparisons between ultrasound data from exams performed by heart failure patients using the study app (both in clinic and at home) and ultrasound exams performed by novice clinicians to pulmonary pressure data from the Abbott CardioMEMS system | Study Completion (91 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Ease of use | Patient and novice clinician reported ease of use and satisfaction based on responses to user surveys. | Study Completion (91 days) |
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Inclusion Criteria:
Exclusion Criteria:
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CHF patients with CardioMEMS devices
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Muir Health Hospital, Concord Medical Center | Concord | California | 94520 | United States | ||
| John Muir Health Hospital, Walnut Creet Medical Center |
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| Walnut Creek |
| California |
| 07724 |
| United States |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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