Heart Failure
Conditions
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.
Interventions
DEVICEAcorai 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.
DEVICEAcorai 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.
Sponsors
Acorai AB
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the ML's performance to estimate pressure | Day 0 to Day 90 | Performance of the ML model trained on data collected from the ASDC System to estimate left-sided filling pressure compared to right heart catheterization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the ML's performance to estimate other hemodynamic parameters | Day 0 to Day 90 | 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. |
| Diagnostic accuracy of ML model | Day 0 to Day 90 | The diagnostic accuracy of the ML model trained on data collected from the ASDC System to detect clinically significant abnormal right heart catheterization measurements. |
Countries
Belgium, Canada, Denmark, Sweden, United Kingdom, United States
Outcome results
None listed