A Multi-site, Pre-clinical, Prospective Data Collection Study in Patients Undergoing a Right Heart Catheterization

Acorai

Status

Not yet enrolling

Conditions

Heart Failure

Treatments

Device: Data collection

Study type

Observational

Funder types

Industry

Identifiers

NCT07010562

Pre-clinical_RHC

Details and patient eligibility

About

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.

Enrollment

392 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.