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

Not yet recruiting

• Conditions: Heart Failure

• Registration Number: NCT07010562
• Lead Sponsor: Acorai AB

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-30
• Study First Submitted QC: 2025-05-30
• Status Verified: 2025-06
• Study First Posted: 2025-06-08
• Last Update Submitted: 2025-06-09
• Last Update Posted: 2025-06-12
• Study Start: 2025-09-01
• Primary Completion: 2026-03-31
• Study Completion: 2026-05-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 392

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of the ML's performance to estimate pressure	Day 0 to Day 90	Performance of the Machine Learning model trained on data collected from the device to estimate left-sided filling pressure compared to right heart catheterization.