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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Start Date
March 1, 2026
Primary Completion Date
June 30, 2026
Completion Date
November 30, 2026
Last Updated
March 6, 2026
392
ESTIMATED participants
Data collection
DEVICE
Lead Sponsor
Acorai AB
NCT07191730
NCT07484009
Data Source & Attribution
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