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Taking people in SwedenNo phase

Collects data from heart failure patients during right heart catheterization

Gathers data to develop a non-invasive device estimating heart pressures in people with heart failure.

Plain-language title generated from the registry record
Registry title: A Multi-site, Prospective, Non-interventional, Observational Data Collection Study in Patients Undergoing a Right Heart Catheterization

Key facts

Where
Lund, SwedenSee the site

Where in Sweden

  • Skåne University Hospital LundLund, SwedenTaking people

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Trial details

Who runs it
Acorai AB
Trial code
NCT07010562
Record updated
13 October 2026
Original description
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.Read full original descriptionShow less

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: 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: 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.

ClinicalTrials.gov NCT07010562