A Multi-site, Pre-clinical, Prospective Data Collection Study in Patients Undergoing a Right Heart Catheterization

NCT07010562 | Not Yet Recruiting

• 1 other identifier: Pre-clinical_RHC
• Study Type: observational
• Target: 392
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Evaluation of the ML's performance to estimate pressure

  Performance of the Machine Learning model trained on data collected from the device to estimate left-sided filling pressure compared to right heart catheterization.

  Day 0 to Day 90

Study Arms (1)

RHC

Patients enrolled for a right heart catheterization procedure as part of their standard of care.

Device: Data collection

Interventions

Data collection DEVICE

A supervised session that includes 10 minutes of patient information entry, 5 minutes of sensor recording time and 10 minutes of margin for setting up the system and patient, thus a total evaluation duration of approximately 25 minutes prior to the Right Heart Catheterization. No follow-up period for the subjects will be required for this clinical investigation. Patients will be followed as per standard of care, at the hospital. A single follow-up observational data collection will be conducted at 90 days, to collect the number of unplanned hospitalizations since the procedure visit. This does not involve active patient participation.

RHC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients enrolled for a right heart catheterization procedure as part of their standard of care.

You may qualify if:

• 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.

Sponsors & Collaborators

• Acorai AB: lead

MeSH Terms

Conditions

Heart Failure

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Rita Peixoto

CONTACT

+460704097192; rita.peixoto@acorai.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 8, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03