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

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT05594940

Recruitment Status : **RECRUITING NOW**
First Posted : October 26, 2022
Last Update Posted : October 26, 2022

Sponsor:

Information provided by (Responsible Party):
Butterfly Network

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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.

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.

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Study Type :
Observational

Estimated Enrollment :
40 participants

Observational Model:
Case-Only

Time Perspective:
Prospective

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

Actual Study Start Date :
September 21, 2022

Estimated Primary Completion Date :
February 1, 2023

Estimated Study Completion Date :
February 1, 2023

Resource links provided by the National Library of Medicine

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Primary Outcome Measures :

Patients Image Quality [ Time Frame: 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

Novice Image Quality [ Time Frame: 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

B-Line count CardioMEMS comparison [ Time Frame: 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 :

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

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Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:  
18 Years and older   (Adult, Older Adult)

Sexes Eligible for Study:  
All

Accepts Healthy Volunteers:  
No

Sampling Method:  
Probability Sample

CHF patients with CardioMEMS devices

Inclusion Criteria:

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.

Exclusion Criteria:

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

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Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05594940

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John Muir Health Hospital, Concord Medical Center

Concord, California, United States, 94520

Principal Investigator: Richard Chang         

John Muir Health Hospital, Walnut Creet Medical Center

Walnut Creek, California, United States, 07724

Principal Investigator: Richard Chang         

Butterfly Network

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Responsible Party:
Butterfly Network

ClinicalTrials.gov Identifier:
NCT05594940    

Other Study ID Numbers:
BN03

First Posted:
October 26, 2022    Key Record Dates

Last Update Posted:
October 26, 2022

Last Verified:
October 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:
No

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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

Keywords provided by Butterfly Network:

CardioMEMSiQ+HomeCHFB-Lines

Additional relevant MeSH terms:

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Heart FailureHeart DiseasesCardiovascular Diseases

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

October 27, 2022Comments OffCardiology | Cardiology Clinical Trials | Cardiology Studies | ClinicalTrials.gov | Drug Trials Near Me | US National Library of Medicine
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