Congestive Heart FailureNCT05594940
Heart Failure Monitoring With a Portable Ultrasound Device With Artificial Intelligence Assisted Tools: A Multi-Phase Observational Feasibility Study
An observational study of Congestive Heart Failure, run by Butterfly Network at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Sep 2022to 23 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: CHF patients with CardioMEMS devices
Who may be able to join
- 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.
Who cannot join
- Previous experience using an ultrasound device on themselves or others
- Women who are pregnant or plan to become pregnant during the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
John Muir Health Hospital, Concord Medical Center
Concord, California, 94520
John Muir Health Hospital, Walnut Creet Medical Center
Walnut Creek, California, 07724
About this 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.
Read the 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.
- Conditions
- Congestive Heart Failure
- Keywords
- CardioMEMS, iQ+, Home, CHF, B-Lines
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Study Completion (91 days)
Secondary outcomes (1)
Ease of use
Patient and novice clinician reported ease of use and satisfaction based on responses to user surveys.
Measured: Study Completion (91 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start21 Sep 2022
- Primary completion23 Feb 2024
- Study completion23 Feb 2024
Why it stopped: Data Analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butterfly Network
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05594940
- Sponsor's protocol ID
- BN03
- Status last verified
- Feb 2024
- First submitted
- 20 Oct 2022
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Failure Monitoring With a Portable Ultrasound Device With Artificial Intelligence Assisted Tools: A Multi-Phase Observational Feasibility Study
- ClinicalTrials.gov ID
- NCT05594940
- Acronym / sponsor ID
- BN03
- Conditions
- Congestive Heart Failure
- Keywords
- CardioMEMS, iQ+, Home, CHF, B-Lines
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Data Analysis
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Butterfly NetworkIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 23 Feb 2024 (actual)
- Study completion
- 23 Feb 2024 (actual)
- First posted
- 26 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CHF patients with CardioMEMS devices
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- Previous experience using an ultrasound device on themselves or others
- Women who are pregnant or plan to become pregnant during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Ease of use
Time frame: Study Completion (91 days)
Results and safety
The study was stopped early (reason given: Data Analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congestive Heart Failure, run by Butterfly Network at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Data Analysis). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients Image Quality (time frame: Study Completion (91 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.