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

NCT05594940 | Terminated

• 1 other identifier: BN03
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 2

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.

Conditions

Congestive Heart Failure

Keywords

CardioMEMS; iQ+; Home; CHF; B-Lines

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Ease of use

  Study Completion (91 days)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

CHF patients with CardioMEMS devices

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Butterfly Network: lead

Study Sites (2)

John Muir Health Hospital, Concord Medical Center

Concord, California, 94520, United States

Location

John Muir Health Hospital, Walnut Creet Medical Center

Walnut Creek, California, 07724, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: October 26, 2022
• Study Start: September 21, 2022
• Primary Completion: February 23, 2024
• Study Completion: February 23, 2024
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)