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

Recruitingn/aAges 18 Years - anyAllAcorai AB
NCT07010562 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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What it tests

  • Data collection
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Where

1 site
Skåne University Hospital - Lund
Lund, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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