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
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
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.