Clinical trial Recruiting at 1 site Observational Ages 18 and up

Non-invasive heart monitoring data collection during right heart catheterization

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

Run by Acorai AB · NCT07010562 · Data updated 2026-11-12

This study tests data collection for training a non-invasive device to estimate heart pressures in adults with suspected or confirmed heart failure or pulmonary hypertension who are having invasive assessments.

More Heart Failure trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment392 (estimated)
SponsorAcorai AB
Industry-sponsored
Locations1 site (Lund)
StatusRecruiting
StartedSeptember 1, 2026
Main results expectedDecember 30, 2026
Study endsFebruary 28, 2027
Registry record updatedOctober 13, 2026
Trial IDNCT07010562 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18 years or older who are referred for invasive hemodynamic assessment with right heart catheterization and can provide informed consent.

Probably not a fit

Patients not undergoing right heart catheterization or not suitable for non-invasive monitoring development may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational, multi-site data collection study in adults undergoing right heart catheterization. Data gathered will support training of machine learning models for a non-invasive monitoring system intended to aid clinical decisions about heart failure and pulmonary congestion. No therapeutic intervention is given; the study relies on standard-of-care procedures and collects additional data for model development. The aim is to create a companion test that helps clinicians interpret intracardiac hemodynamic status. Results will inform future validation of the device and its potential role in patient care.

Why it matters

Potential benefit: If successful, the non-invasive tool could help clinicians assess intracardiac pressures and congestion more easily, potentially guiding treatment decisions.

How similar studies have gone: Prior similar efforts in non-invasive hemodynamic monitoring have shown varying degrees of promise; this work builds on established concepts but remains exploratory for machine-learning-driven estimation.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Skåne University Hospital - Lund
    Lund, Sweden
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.