- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05835024
Acorai MLG Study (Machine Learning Generalisation)
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
-
London, United Kingdom
- Recruiting
- Harefield Hospital
-
Contact:
- Geraldine Sloane
- Phone Number: +44 (0) 330 128 8815
- Email: g.sloane@rbht.nhs.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Participants
Patients enrolled for a right heart catheterization procedure as part of their standard of care.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy of ML
Time Frame: Day 0 to Day 90
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Abnormal RHC measurements
Time Frame: Day 0 to Day 90
|
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
|
NT-proBNP
Time Frame: Day 0 to Day 90
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ASDC-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Heart Failure
-
Tufts Medical CenterMetro West Medical CenterCompletedCongestive Heart Failure | Diastolic Heart Failure | Systolic Heart FailureUnited States
-
Abbott Medical DevicesCompletedHeart Failure | Heart Failure, Diastolic | Heart Failure, Systolic | Heart Failure NYHA Class II | Heart Failure NYHA Class III | Heart Failure With Reduced Ejection Fraction | Heart Failure NYHA Class IV | Heart Failure With Normal Ejection Fraction | Heart Failure; With Decompensation | Heart Failure...United States, Canada
-
Manipal UniversityUnknownHeart Failure | Decompensated Heart Failure | Acute Heart Failure | Diastolic Heart Failure | Systolic Heart FailureIndia
-
VA Eastern Colorado Health Care SystemNational Institute on Aging (NIA)CompletedHeart Failure | Heart Failure, Diastolic | Heart Failure, Systolic | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection Fraction | Heart Failure; With Decompensation | Heart Failure,Congestive | Heart Failure AcuteUnited States
-
University Hospital, MontpellierCompletedHeart Failure | Diastolic Heart Failure | Systolic Heart Failure Stage CFrance
-
Wake Forest UniversityCompletedHeart Failure, Congestive | Heart Failure With Preserved Ejection Fraction
-
Wake Forest UniversityNational Institute on Aging (NIA)CompletedHeart Failure, Congestive | Diastolic Heart FailureUnited States
-
Lancaster General HospitalLouise von Hess Medical Research InstituteEnrolling by invitationDiastolic Heart FailureUnited States
-
Giresun UniversityIstanbul University - Cerrahpasa (IUC)RecruitingHeart Failure | Diastolic Heart Failure | Systolic Heart FailureTurkey
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Duke University; St. Paul's Hospital... and other collaboratorsActive, not recruitingHeart Diseases | Heart Failure | Transplant; Failure, Heart | Heart Transplant Failure and Rejection | Heart Failure,Congestive | Transplant FailureCanada, United States
Clinical Trials on Acorai Sensor Data Collection (ASDC) system 1.0
-
Boehringer IngelheimCompletedPulmonary FibrosisUnited States, Germany, Netherlands, Belgium
-
University Hospital, Basel, SwitzerlandRecruitingCardiomyopathy | Arrhythmia-induced Cardiomyopathy (AiCM)Switzerland
-
University Hospital, Basel, SwitzerlandCompletedDegenerative Lumbar Spine DiseasesSwitzerland
-
Centre Hospitalier Universitaire de Saint EtienneRecruitingHepatectomy | LaparoscopyFrance
-
Medtronic DiabetesCompletedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
Istituto Clinico HumanitasSocieta Italiana Anestesia Analgesia Rianimazione e Terapia IntensivaRecruitingFrailty | Anesthesia | Thoracic Surgery | Cardiothoracic Surgery | Vascular Surgery | Comorbidities and Coexisting ConditionsItaly
-
University Hospital, Basel, SwitzerlandCompletedStatus Epilepticus | Refractory Status EpilepticusSwitzerland
-
University Hospital, Basel, SwitzerlandRecruitingPostoperative Delirium | Postoperative Cognitive Dysfunction | Postoperative StrokeGermany, Switzerland, United Kingdom
-
Memorial Sloan Kettering Cancer CenterCompletedProstate CancerUnited States
-
M.D. Anderson Cancer CenterRecruitingEndocrine DiseaseUnited States