Acorai Machine Learning Generalization (MLG) Study (CAPTURE-HF)

Acorai

Status

Completed

Conditions

Heart Failure

Treatments

Device: Acorai Sensor Data Collection (ASDC) system 1.0 - Phase 2

Device: Acorai Sensor Data Collection (ASDC) system 1.0 - Phase 1

Study type

Observational

Funder types

Industry

Identifiers

NCT05835024

ASDC-1

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

1,602 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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