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 Type
OBSERVATIONAL
Enrollment
1,602
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.
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.
Conway Regional Cardiovascular Clinic
Conway, Arkansas, United States
Baptist Health Medical Centre
Little Rock, Arkansas, United States
Mayo Clinic
Jacksonville, Florida, United States
Cleveland Clinic Martin Health
Stuart, Florida, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
WakeMed
Raleigh, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
Austin Heart Central and San Marcos
Austin, Texas, United States
Austin Heart Round Rock
Austin, Texas, United States
...and 8 more locations
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.
Time frame: 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.
Time frame: Day 0 to Day 90
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.
Time frame: Day 0 to Day 90
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