A Multi-site, Prospective, Non-interventional, Observational Data Collection Study in Patients Undergoing a Right Heart Catheterization

A Multi-site, Prospective, Non-interventional, Observational Data Collection Study in Patients Undergoing a Right Heart Catheterization

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.

Inclusion Criteria:

• Subject is at least 18 years of age at the time of screening.
• Subject is willing and physically able to comply with the specified evaluations as per the protocol.
• Subject is referred for invasive hemodynamic assessment with right heart catheterization.
• Subject has provided written informed consent using the approved consent form.

Exclusion Criteria:

• Discretionary exclusion when the inclusion of a potential subject is not in their best interest or not in the interest of compliant performance of the study.