Clinical Trial

A Multi-site, Prospective, Non-interventional, Observational Data Collection Study in Patients Undergoing a Right Heart Catheterization

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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.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2026-06-30 -> 2026-12-30 2026-07-01
minor Completion pushed: 2026-11-30 -> 2027-02-28 2026-07-01
Trial Details
NCT Number NCT07010562
Lead Sponsor Acorai AB
Conditions Heart Failure
Enrollment 392 participants
Start Date 2026-07-01
Primary Completion 2026-12-30 (estimated)
Study Completion 2027-02-28 (estimated)
Updated on ClinicalTrials.gov 2026-06-30