NCT05835024Completed
Acorai Machine Learning Generalization (MLG) Study
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 Evaluation of a Novel maChine leArning Model's Performance for Non-invasive inTracardiac pressURE Monitoring in Heart Failure - The CAPTURE-HF Trial
Source: ClinicalTrials.gov · Last updated 3 Dec 2024
Brief summary (registry, in English)
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 (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1602 (actual)
- First submitted
- 18 Apr 2023
- Start date
- 15 Aug 2023
- Primary completion date
- 31 Oct 2024
- Lead sponsor
- Acorai AB
- Diseases
- Heart failure
- NCT number
- NCT05835024
What you commit to
- Study type: Observational
- Participants enrolled: 1602
- From 15 Aug 2023 to the primary completion date, 31 Oct 2024
- 18 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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.
- Subjects who are pregnant are excluded in the US
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (18)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Onze-Lieve-Vrouwziekenhuis (OLV) Hospital Aalst Coordinator of this site? Confirm its status | Aalst | Belgium | Unknown status |
| University of Ottawa Heart Institute Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| Toronto General Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Mount Sinai Hospital Toronto Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Rigshospitalet, University Hospital of Copenhagen Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
| Royal Brompton and Harefield Hospitals Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Southampton University Hospital Coordinator of this site? Confirm its status | Southampton | United Kingdom | Unknown status |
| Sahlgrenska University Hospital Coordinator of this site? Confirm its status | Gothenburg | Sweden | Unknown status |
| Austin Heart Round Rock Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Austin Heart Central and San Marcos Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Medical University of South Carolina (MUSC) Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Conway Regional Cardiovascular Clinic Coordinator of this site? Confirm its status | Conway | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Saint Luke's Hospital of Kansas City Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Baptist Health Medical Centre Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Wakemed Coordinator of this site? Confirm its status | Raleigh | United States | Unknown status |
| Cleveland Clinic Martin Health Coordinator of this site? Confirm its status | Stuart | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.