Acorai MLG Study (Machine Learning Generalisation)

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

Study Description

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

• 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

Groups and Cohorts

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

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

• 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

Locations

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

• Responsible Party: Acorai AB
• ClinicalTrials.gov Identifier: NCT05835024
• Other Study ID Numbers: ASDC-1
• First Posted: April 28, 2023
• Last Update Posted: August 29, 2023
• Last Verified: August 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Heart Failure; Heart Diseases; Cardiovascular Diseases