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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
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

Full criteria on ClinicalTrials.gov

Sites (18)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Onze-Lieve-Vrouwziekenhuis (OLV) Hospital Aalst
Coordinator of this site? Confirm its status
AalstBelgiumUnknown status
University of Ottawa Heart Institute
Coordinator of this site? Confirm its status
OttawaCanadaUnknown status
Toronto General Hospital
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status
Mount Sinai Hospital Toronto
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TorontoCanadaUnknown status
Rigshospitalet, University Hospital of Copenhagen
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CopenhagenDenmarkUnknown status
Royal Brompton and Harefield Hospitals
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
Southampton University Hospital
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SouthamptonUnited KingdomUnknown status
Sahlgrenska University Hospital
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GothenburgSwedenUnknown status
Austin Heart Round Rock
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AustinUnited StatesUnknown status
Austin Heart Central and San Marcos
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AustinUnited StatesUnknown status
Medical University of South Carolina (MUSC)
Coordinator of this site? Confirm its status
CharlestonUnited StatesUnknown status
Conway Regional Cardiovascular Clinic
Coordinator of this site? Confirm its status
ConwayUnited StatesUnknown status
Mayo Clinic
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JacksonvilleUnited StatesUnknown status
Saint Luke's Hospital of Kansas City
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Kansas CityUnited StatesUnknown status
Baptist Health Medical Centre
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Little RockUnited StatesUnknown status
University of Pennsylvania
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PhiladelphiaUnited StatesUnknown status
Wakemed
Coordinator of this site? Confirm its status
RaleighUnited StatesUnknown status
Cleveland Clinic Martin Health
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StuartUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.