Heart Failure Clinical Trial

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

Summary

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.

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Full Description

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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Eligibility Criteria

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

Study is for people with:

Heart Failure

Estimated Enrollment:

22

Study ID:

NCT05594940

Recruitment Status:

Terminated

Sponsor:

Butterfly Network

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There are 2 Locations for this study

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John Muir Health Hospital, Concord Medical Center
Concord California, 94520, United States
John Muir Health Hospital, Walnut Creet Medical Center
Walnut Creek California, 07724, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

22

Study ID:

NCT05594940

Recruitment Status:

Terminated

Sponsor:


Butterfly Network

How clear is this clinincal trial information?

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