Heart Failure Monitoring With a Portable Ultrasound Device With Artificial Intelligence Assisted Tools: A Multi-Phase Observational Feasibility Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Heart Failure Monitoring With a Portable Ultrasound Device With Artificial Intelligence Assisted Tools: A Multi-Phase Observational Feasibility Study

Conditions
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Congestive Heart Failure

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Documented diagnosis of heart failure at least three months prior to the date of consent HF currently managed with the Abbott CardioMEMS device Able to read and write in English. At least 18 years of age or older on the date of consent. Willing and able to provide written consent to participation Expressed willingness to capture AI assisted US recordings immediately before or after taking their CardioMEMS measurements Access to WiFi or cellular data connection at home In the opinion of the investigator or delegate the subject, must be capable of complying with study procedures. Exclusion Criteria: Previous experience using an ultrasound device on themselves or others Women who are pregnant or plan to become pregnant during the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CardioMEMS, iQ+, Home, CHF, B-Lines