Acorai Machine Learning Generalization (MLG) Study (CAPTURE-HF)

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: Acorai Sensor Data Collection (ASDC) system 1.0 - Phase 1; Device: Acorai Sensor Data Collection (ASDC) system 1.0 - Phase 2

• Study Type: Observational
• Enrollment (Actual): 1602

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium
    • Onze-Lieve-Vrouwziekenhuis (OLV) Hospital Aalst
• Canada
  • Ottawa, Canada
    • University of Ottawa Heart Institute
  • Toronto, Canada
    • Toronto General Hospital
  • Toronto, Canada
    • Mount Sinai Hospital Toronto
• Denmark
  • Copenhagen, Denmark
    • Rigshospitalet, University Hospital of Copenhagen
• Sweden
  • Gothenburg, Sweden
    • Sahlgrenska University Hospital
• United Kingdom
  • London, United Kingdom
    • Royal Brompton and Harefield Hospitals
  • Southampton, United Kingdom
    • Southampton University Hospital
• United States
  • Arkansas
    • Conway, Arkansas, United States, 72034
      • Conway Regional Cardiovascular Clinic
    • Little Rock, Arkansas, United States, 72205
      • Baptist Health Medical Centre
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic
    • Stuart, Florida, United States, 34994
      • Cleveland Clinic Martin Health
  • Missouri
    • Kansas City, Missouri, United States, 641111
      • Saint Luke's Hospital of Kansas City
  • North Carolina
    • Raleigh, North Carolina, United States, 27610
      • WakeMed
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina (MUSC)
  • Texas
    • Austin, Texas, United States, 78756
      • Austin Heart Central and San Marcos
    • Austin, Texas, United States, 78756
      • Austin Heart Round Rock

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

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.
• Subjects who are pregnant are excluded in the US

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants phase 1; Phase 1: patients enrolled for a right heart catheterization procedure as part of their standard of care.	Device: Acorai Sensor Data Collection (ASDC) system 1.0 - Phase 1; 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.
Participants phase 2; Phase 2: patients enrolled for a right heart catheterization procedure as part of their standard of care.	Device: Acorai Sensor Data Collection (ASDC) system 1.0 - Phase 2; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 0 to Day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 0 to Day 90
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.	Day 0 to Day 90

Collaborators and Investigators

• Sponsor: Acorai AB

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2023
• Primary Completion (Actual): October 31, 2024
• Study Completion (Actual): October 31, 2024

Study Registration Dates

• First Submitted: April 18, 2023
• First Submitted That Met QC Criteria: April 18, 2023
• First Posted (Actual): April 28, 2023

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: December 2, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: ASDC-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No