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

Congestive Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05594940
• Other study ID #: BN03
• Status: Terminated
• Start date: September 21, 2022
• Est. completion date: February 23, 2024

Study information

• Verified date: February 2024
• Source: Butterfly Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: February 23, 2024
• Est. primary completion date: February 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Locations

Country	Name	City	State
United States	John Muir Health Hospital, Concord Medical Center	Concord	California
United States	John Muir Health Hospital, Walnut Creet Medical Center	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Butterfly Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	Ease of use	Patient and novice clinician reported ease of use and satisfaction based on responses to user surveys.	Study Completion (91 days)