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Life sciences · Observational Study
ClinicalTrials.gov · October 13, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT07010562). This is a study registration, not published results. Lead sponsor: Acorai AB. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 392 participants (ESTIMATED). Conditions: Heart Failure. Interventions: DEVICE: Data collection. Primary outcome measures: Evaluation of the ML's performance to estimate pressure , Day 0 to Day 90. Brief summary: 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.