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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 392 (estimated) |
| Sponsor | Acorai AB Industry-sponsored |
| Locations | 1 site (Lund) |
| Status | Recruiting |
| Started | September 1, 2026 |
| Main results expected | December 30, 2026 |
| Study ends | February 28, 2027 |
| Registry record updated | October 13, 2026 |
| Trial ID | NCT07010562 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
- Study coordinator: Rita Peixoto
- Email: rita.peixoto@acorai.com
- Phone: +460704097192
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.