Heart Failure Clinical Trial
Official title:
A Multi-Site Observational Clinical Investigation to Collect Non-invasive Sensor Data During a Right Heart Catheterization and Train Machine Learning Models to Estimate Intracardiac Hemodynamic Parameters
NCT number | NCT05835024 |
Other study ID # | ASDC-1 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | August 15, 2023 |
Est. completion date | December 30, 2023 |
Verified date | August 2023 |
Source | Acorai AB |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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 | Recruiting |
Enrollment | 1214 |
Est. completion date | December 30, 2023 |
Est. primary completion date | December 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Subject is, at least, 18 years of age at the time of screening visit. - Subject is willing and physically able to comply with the specified evaluations as per the clinical investigation plan, as assessed by the investigator. - Subject is referred for invasive hemodynamic assessment with right heart cardiac catheterization. - Patient has provided written informed consent using the Ethics Committee/ Institutional Review Board approved consent form. Exclusion Criteria: - Discretionary exclusion when, in the opinion of the investigator, the inclusion of a potential subject is not in their best interest or not in the interest of compliant performance of the clinical investigation. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Harefield Hospital | London |
Lead Sponsor | Collaborator |
---|---|
Acorai AB |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Accuracy of ML | Accuracy of the machine learning models trained on data collected from the ASDC system to estimate measurements obtained during a right heart catheterization. | Day 0 to Day 90 | |
Secondary | Abnormal RHC measurements | The diagnostic accuracy of the machine learning models trained on data collected from the ASDC system to detect clinically significant abnormal right heart catheterization measurements. | Day 0 to Day 90 | |
Secondary | NT-proBNP | Accuracy of the combination of NT-proBNP with the optimal machine learning model to estimate measurements obtained during a right heart catheterization. | Day 0 to Day 90 |
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