Heart FailureCAPTURE-HFNCT05835024
Acorai Machine Learning Generalization (MLG) Study
An observational study of Heart Failure, run by Acorai AB at 18 sites in 6 countries.
Trial summary
Acorai is developing a non-invasive monitoring system for the estimation of intracardiac hemodynamic parameters in patients with suspected or confirmed heart failure, and/or pulmonary hypertension, who require hemodynamic assessment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Acorai Sensor Data Collection (ASDC) system 1.0 - Phase 1 and Acorai Sensor Data Collection (ASDC) system 1.0 - Phase 2
- Type of treatment
- Medical device
- How many people
- 1,602 participants
- Where
- 18 sitesin 6 countries
- Study dates
- 15 Aug 2023to 31 Oct 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients enrolled for a right heart catheterization procedure as part of their standard of care.
Who may be able to join
- Subject is, at least, 18 years of age at the time of screening visit.
- Subject is willing and physically able to comply with the specified evaluations as per the clinical investigation plan, as assessed by the investigator.
- Subject is referred for invasive hemodynamic assessment with right heart cardiac catheterization.
- Patient has provided written informed consent using the Ethics Committee/ Institutional Review Board approved consent form.
Who cannot join
- Discretionary exclusion when, in the opinion of the investigator, the inclusion of a potential subject is not in their best interest or not in the interest of compliant performance of the clinical investigation.
- Subjects who are pregnant are excluded in the US
Trial locations and contacts
18 sites in 6 countries.
18 sites in 6 countries
United States10 sites
Austin Heart Central and San Marcos
Austin, Texas, 78756
Austin Heart Round Rock
Austin, Texas, 78756
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425
Conway Regional Cardiovascular Clinic
Conway, Arkansas, 72034
Mayo Clinic
Jacksonville, Florida, 32224
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 641111
Baptist Health Medical Centre
Little Rock, Arkansas, 72205
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
WakeMed
Raleigh, North Carolina, 27610
Cleveland Clinic Martin Health
Stuart, Florida, 34994
Canada3 sites
University of Ottawa Heart Institute
Ottawa
Mount Sinai Hospital Toronto
Toronto
Toronto General Hospital
Toronto
United Kingdom2 sites
Royal Brompton and Harefield Hospitals
London
Southampton University Hospital
Southampton
About this study
Official title: A Multi-Site Observational Clinical Investigation to Collect Non-invasive Sensor Data During a Right Heart Catheterization and Train Machine Learning Models to Estimate Intracardiac Hemodynamic Parameters Evaluation of a Novel maChine leArning Model's Performance for Non-invasive inTracardiac pressURE Monitoring in Heart Failure - The CAPTURE-HF Trial
Acorai is developing a non-invasive monitoring system for the estimation of intracardiac hemodynamic parameters in patients with suspected or confirmed heart failure, and/or pulmonary hypertension, who require hemodynamic assessment. The device will be intended as a companion test or clinical decision support tool to be used and interpreted by qualified healthcare professionals to aid standard-of-care clinical assessment in identifying hemodynamic congestion and supporting personalized treatment of heart failure and pulmonary congestion.
This study is part of the development of a non-invasive monitoring system for the estimation of intracardiac hemodynamic parameters. It will be conducted to collect the data needed to train the machine learning models retrospectively.
- Conditions
- Heart Failure
- Being tested
- Acorai Sensor Data Collection (ASDC) system 1.0 - Phase 1, Acorai Sensor Data Collection (ASDC) system 1.0 - Phase 2
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acorai Sensor Data Collection (ASDC) system 1.0 - Phase 1Device
A supervised session that includes 10 minutes of patient information entry, 5 minutes of sensor recording time and 10 minutes of margin for setting up the system and patient, thus a total evaluation duration of approximately 25 minutes prior to the Right Heart Catheterization.
No follow-up period for the subjects will be required for this clinical investigation. Patients will be followed as per standard of care, at the hospital.
A single follow-up observational data collection will be conducted at 90 days, to collect the number of unplanned hospitalizations since the procedure visit. This does not involve active patient participation.
Acorai Sensor Data Collection (ASDC) system 1.0 - Phase 2Device
A supervised session that includes 10 minutes of patient information entry, 5 minutes of sensor recording time and 10 minutes of margin for setting up the system and patient, thus a total evaluation duration of approximately 25 minutes prior to the Right Heart Catheterization.
No follow-up period for the subjects will be required for this clinical investigation. Patients will be followed as per standard of care, at the hospital.
| Study group | Role | What they receive |
|---|---|---|
| Participants phase 1 | Phase 1: patients enrolled for a right heart catheterization procedure as part of their standard of care. Receives: Device: Acorai Sensor Data Collection (ASDC) system 1.0 - Phase 1 | |
| Participants phase 2 | Phase 2: patients enrolled for a right heart catheterization procedure as part of their standard of care. Receives: Device: Acorai Sensor Data Collection (ASDC) system 1.0 - Phase 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the ML's performance to estimate pressure
Performance of the ML model trained on data collected from the ASDC System to estimate left-sided filling pressure compared to right heart catheterization.
Measured: Day 0 to Day 90
Secondary outcomes (2)
Evaluation of the ML's performance to estimate other hemodynamic parameters
The performance of the ML model trained on data collected from the ASDC System to estimate other hemodynamic parameters (such as right atrial pressure) compared to right heart catheterization.
Measured: Day 0 to Day 90
Diagnostic accuracy of ML model
The diagnostic accuracy of the ML model trained on data collected from the ASDC System to detect clinically significant abnormal right heart catheterization measurements.
Measured: Day 0 to Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start15 Aug 2023
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,602 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acorai AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05835024
- Sponsor's protocol ID
- ASDC-1
- Acronym
- CAPTURE-HF
- Status last verified
- Dec 2024
- First submitted
- 18 Apr 2023
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Site Observational Clinical Investigation to Collect Non-invasive Sensor Data During a Right Heart Catheterization and Train Machine Learning Models to Estimate Intracardiac Hemodynamic Parameters Evaluation of a Novel maChine leArning Model's Performance for Non-invasive inTracardiac pressURE Monitoring in Heart Failure - The CAPTURE-HF Trial
- ClinicalTrials.gov ID
- NCT05835024
- Acronym / sponsor ID
- CAPTURE-HF / ASDC-1
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,602 participants (actual)
- Lead sponsor
- Acorai ABIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 28 Apr 2023 (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.
Acorai is developing a non-invasive monitoring system for the estimation of intracardiac hemodynamic parameters in patients with suspected or confirmed heart failure, and/or pulmonary hypertension, who require hemodynamic assessment. The device will be intended as a companion test or clinical decision support tool to be used and interpreted by qualified healthcare professionals to aid standard-of-care clinical assessment in identifying hemodynamic congestion and supporting personalized treatment of heart failure and pulmonary congestion.
This study is part of the development of a non-invasive monitoring system for the estimation of intracardiac hemodynamic parameters. It will be conducted to collect the data needed to train the machine learning models retrospectively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants phase 1 | – | Device: Acorai Sensor Data Collection (ASDC) system 1.0 - Phase 1Phase 1: patients enrolled for a right heart catheterization procedure as part of their standard of care. |
| Participants phase 2 | – | Device: Acorai Sensor Data Collection (ASDC) system 1.0 - Phase 2Phase 2: patients enrolled for a right heart catheterization procedure as part of their standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients enrolled for a right heart catheterization procedure as part of their standard of care.
Key inclusion criteria (4 listed)
- Subject is, at least, 18 years of age at the time of screening visit.
- Subject is willing and physically able to comply with the specified evaluations as per the clinical investigation plan, as assessed by the investigator.
- Subject is referred for invasive hemodynamic assessment with right heart cardiac catheterization.
- Patient has provided written informed consent using the Ethics Committee/ Institutional Review Board approved consent form.
Key exclusion criteria (2 listed)
- Discretionary exclusion when, in the opinion of the investigator, the inclusion of a potential subject is not in their best interest or not in the interest of compliant performance of the clinical investigation.
- Subjects who are pregnant are excluded in the US
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acorai Sensor Data Collection (ASDC) system 1.0 - Phase 1A supervised session that includes 10 minutes of patient information entry, 5 minutes of sensor recording time and 10 minutes of margin for setting up the system and patient, thus a total evaluation duration of approximately 25 minutes prior to the Right Heart Catheterization. No follow-up period for the subjects will be required for this clinical investigation. Patients will be followed as per standard of care, at the hospital. A single follow-up observational data collection will be conducted at 90 days, to collect the number of unplanned hospitalizations since the procedure visit. This does not involve active patient participation. | Device | Participants phase 1 |
| Acorai Sensor Data Collection (ASDC) system 1.0 - Phase 2A supervised session that includes 10 minutes of patient information entry, 5 minutes of sensor recording time and 10 minutes of margin for setting up the system and patient, thus a total evaluation duration of approximately 25 minutes prior to the Right Heart Catheterization. No follow-up period for the subjects will be required for this clinical investigation. Patients will be followed as per standard of care, at the hospital. | Device | Participants phase 2 |
Primary outcome
Evaluation of the ML's performance to estimate pressure
Time frame: Day 0 to Day 90
Performance of the ML model trained on data collected from the ASDC System to estimate left-sided filling pressure compared to right heart catheterization.
2 secondary outcomes
Evaluation of the ML's performance to estimate other hemodynamic parameters
Time frame: Day 0 to Day 90
Diagnostic accuracy of ML model
Time frame: Day 0 to Day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
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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.
18 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Acorai AB at 18 sites in 6 countries.
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 4 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: finished, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Canada, United Kingdom, Belgium, Denmark and 1 more country. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluation of the ML's performance to estimate pressure (time frame: Day 0 to Day 90). 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 3 Dec 2024.