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

Terminated

• Conditions: Congestive Heart Failure

• Registration Number: NCT05594940
• Lead Sponsor: Butterfly Network

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2022-09-21
• Study First Submitted: 2022-10-20
• Study First Submitted QC: 2022-10-24
• Study First Posted: 2022-10-26
• Status Verified: 2024-02
• Primary Completion: 2024-02-23
• Study Completion: 2024-02-23
• Last Update Submitted: 2024-02-23
• Last Update Posted: 2024-02-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Novice Image Quality	Study Completion (91 days)	Image quality comparisons between ultrasound scans performed by novice clinicians using the study app to traditional ultrasound scans performed by trained clinicians
Patients Image Quality	Study Completion (91 days)	Image quality comparisons between ultrasound scans performed by heart failure patients using the study app to traditional ultrasound scans performed by trained clinicians
B-Line count CardioMEMS comparison	Study Completion (91 days)	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

Secondary Outcome Measures

Name	Time	Method
Ease of use	Study Completion (91 days)	Patient and novice clinician reported ease of use and satisfaction based on responses to user surveys.

Trial Locations

Locations (2)

John Muir Health Hospital, Concord Medical Center; 🇺🇸 Concord, California, United States

John Muir Health Hospital, Walnut Creet Medical Center; 🇺🇸 Walnut Creek, California, United States