Acorai Machine Learning Generalization (MLG) Study
Completed
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
- NCT05835024
- Run by
- Acorai AB
- People needed
- 1602
- Starts
- 2023-08-15
- Expected to finish
- 2024-10-31
- Last updated by the study team
- 2024-12-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Conway Regional Cardiovascular Clinic — Conway, Arkansas, United States
- Baptist Health Medical Centre — Little Rock, Arkansas, United States
- Mayo Clinic — Jacksonville, Florida, United States
- Cleveland Clinic Martin Health — Stuart, Florida, United States
- Saint Luke's Hospital of Kansas City — Kansas City, Missouri, United States
- WakeMed — Raleigh, North Carolina, United States
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
- Medical University of South Carolina (MUSC) — Charleston, South Carolina, United States
- Austin Heart Central and San Marcos — Austin, Texas, United States
- Austin Heart Round Rock — Austin, Texas, United States
- Onze-Lieve-Vrouwziekenhuis (OLV) Hospital Aalst — Aalst, Belgium
- University of Ottawa Heart Institute — Ottawa, Canada
- Mount Sinai Hospital Toronto — Toronto, Canada
- Toronto General Hospital — Toronto, Canada
- Rigshospitalet, University Hospital of Copenhagen — Copenhagen, Denmark
- Sahlgrenska university hospital — Gothenburg, Sweden
- Royal Brompton and Harefield Hospitals — London, United Kingdom
- Southampton University Hospital — Southampton, United Kingdom
Full record on ClinicalTrials.gov
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