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NCT07010562Recruiting

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

Source: ClinicalTrials.gov · Last updated 13 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
392 (estimated)
First submitted
30 May 2025
Start date
1 Sept 2026
Primary completion date
30 Dec 2026
Lead sponsor
Acorai AB
NCT number
NCT07010562

What you commit to

  • Study type: Observational
  • Planned participants: 392
  • From 1 Sept 2026 to the primary completion date, 30 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Skåne University Hospital Lund
Coordinator of this site? Confirm its status
LundSwedenRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.