A Multi-site, Prospective, Non-interventional, Observational Data Collection Study in Patients Undergoing a Right Heart Catheterization
Starting soon
Conditions studied: Heart Failure
In brief
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.
Key facts
- Study ID
- NCT07010562
- Run by
- Acorai AB
- People needed
- 392
- Starts
- 2026-07-01
- Expected to finish
- 2027-02-28
- Last updated by the study team
- 2026-06-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Full record on ClinicalTrials.gov
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