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Acorai MLG Study (Machine Learning Generalisation)

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ClinicalTrials.gov Identifier: NCT05835024
Recruitment Status : Recruiting
First Posted : April 28, 2023
Last Update Posted : August 29, 2023
Sponsor:
Information provided by (Responsible Party):
Acorai AB

Study Description
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Brief 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. 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.


Condition or disease Intervention/treatment
Heart Failure Device: Acorai Sensor Data Collection (ASDC) system 1.0

Study Design
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Study Type : Observational
Estimated Enrollment : 1214 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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
Actual Study Start Date : August 15, 2023
Estimated Primary Completion Date : December 30, 2023
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Groups and Cohorts
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Group/Cohort Intervention/treatment
Participants
Patients enrolled for a right heart catheterization procedure as part of their standard of care.
 Device: Acorai Sensor Data Collection (ASDC) system 1.0

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.


Outcome Measures
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Primary Outcome Measures :
  1. Accuracy of ML [ Time Frame: Day 0 to Day 90 ]
    Accuracy of the machine learning models trained on data collected from the ASDC system to estimate measurements obtained during a right heart catheterization.


Secondary Outcome Measures :
  1. Abnormal RHC measurements [ Time Frame: Day 0 to Day 90 ]
    The diagnostic accuracy of the machine learning models trained on data collected from the ASDC system to detect clinically significant abnormal right heart catheterization measurements.

  2. NT-proBNP [ Time Frame: Day 0 to Day 90 ]
    Accuracy of the combination of NT-proBNP with the optimal machine learning model to estimate measurements obtained during a right heart catheterization.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients enrolled for a right heart catheterization procedure as part of their standard of care.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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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): NCT05835024


Locations
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United Kingdom
Harefield Hospital Recruiting
London, United Kingdom
Contact: Geraldine Sloane    +44 (0) 330 128 8815    g.sloane@rbht.nhs.uk   
Sponsors and Collaborators
Acorai AB
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Acorai AB
ClinicalTrials.gov Identifier: NCT05835024    
Other Study ID Numbers: ASDC-1
First Posted: April 28, 2023    Key Record Dates
Last Update Posted: August 29, 2023
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases