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

Butterfly Network

Status: Terminated

Conditions: Congestive Heart Failure

Study type: Observational

Funder types: Industry

Identifiers

NCT05594940

BN03

Details and patient eligibility

About

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.

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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Documented diagnosis of heart failure at least three months prior to the date of consent
2. HF currently managed with the Abbott CardioMEMS device
3. Able to read and write in English.
4. At least 18 years of age or older on the date of consent.
5. Willing and able to provide written consent to participation
6. Expressed willingness to capture AI assisted US recordings immediately before or after taking their CardioMEMS measurements
7. Access to WiFi or cellular data connection at home
8. In the opinion of the investigator or delegate the subject, must be capable of complying with study procedures.

Exclusion criteria

1. Previous experience using an ultrasound device on themselves or others
2. Women who are pregnant or plan to become pregnant during the study