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Acorai MLG Study (Machine Learning Generalisation)

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

Tracking Information
First Submitted Date April 18, 2023
First Posted Date April 28, 2023
Last Update Posted Date August 29, 2023
Actual Study Start Date August 15, 2023
Estimated Primary Completion Date December 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 18, 2023)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 18, 2023)
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Acorai MLG Study (Machine Learning Generalisation)
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
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients enrolled for a right heart catheterization procedure as part of their standard of care.
Condition Heart Failure
Intervention 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.

Study Groups/Cohorts Participants
Patients enrolled for a right heart catheterization procedure as part of their standard of care.
Intervention: Device: Acorai Sensor Data Collection (ASDC) system 1.0
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 18, 2023)
1214
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 30, 2023
Estimated Primary Completion Date December 30, 2023   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT05835024
Other Study ID Numbers ASDC-1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Acorai AB
Original Responsible Party Same as current
Current Study Sponsor Acorai AB
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Acorai AB
Verification Date August 2023