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

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.

Study Overview

• Status: Terminated
• Conditions: Congestive Heart Failure

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 Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

CHF patients with CardioMEMS devices

Description

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 Plan

How is the study designed?

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Butterfly Network

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2022
• Primary Completion (Actual): February 23, 2024
• Study Completion (Actual): February 23, 2024

Study Registration Dates

• First Submitted: October 20, 2022
• First Submitted That Met QC Criteria: October 24, 2022
• First Posted (Actual): October 26, 2022

Study Record Updates

• Last Update Posted (Actual): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: CHF; Home; CardioMEMS; iQ+; B-Lines
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: BN03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes