NCT05835024

Acorai Machine Learning Generalization (MLG) Study

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,602 (actual)
• Sponsor: Acorai AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2023-08-15
• Primary completion: 2024-10-31
• Completion: 2024-10-31
• First posted: 2023-04-28
• Last updated: 2024-12-03

Locations

18 sites across 6 countries: United States, Belgium, Canada, Denmark, Sweden, United Kingdom