Clinical trial NCT05835024: Acorai Machine Learning Generalization (MLG) Study
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 Evaluation of a Novel maChine leArning Model's Performance for Non-invasive inTracardiac pressURE Monitoring in Heart Failure - The CAPTURE-HF Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Acorai AB
Sponsor class: INDUSTRY
First posted: 2023-04-28
Enrollment: 1602
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients enrolled for a right heart catheterization procedure as part of their standard of care.

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.


Eligibility criteria: 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.
* Subjects who are pregnant are excluded in the US

Primary outcomes:
measure: Evaluation of the ML's performance to estimate pressure
timeFrame: Day 0 to Day 90
Secondary outcomes:
measure: Evaluation of the ML's performance to estimate other hemodynamic parameters
timeFrame: Day 0 to Day 90
measure: Diagnostic accuracy of ML model
timeFrame: Day 0 to Day 90
Other outcomes:
Locations:
city: Conway
country: United States
facility: Conway Regional Cardiovascular Clinic
state: Arkansas
city: Little Rock
country: United States
facility: Baptist Health Medical Centre
state: Arkansas
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Stuart
country: United States
facility: Cleveland Clinic Martin Health
state: Florida
city: Kansas City
country: United States
facility: Saint Luke's Hospital of Kansas City
state: Missouri
city: Raleigh
country: United States
facility: WakeMed
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina (MUSC)
state: South Carolina
city: Austin
country: United States
facility: Austin Heart Central and San Marcos
state: Texas
city: Austin
country: United States
facility: Austin Heart Round Rock
state: Texas
city: Aalst
country: Belgium
facility: Onze-Lieve-Vrouwziekenhuis (OLV) Hospital Aalst
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
city: Toronto
country: Canada
facility: Mount Sinai Hospital Toronto
city: Toronto
country: Canada
facility: Toronto General Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet, University Hospital of Copenhagen
city: Gothenburg
country: Sweden
facility: Sahlgrenska university hospital
city: London
country: United Kingdom
facility: Royal Brompton and Harefield Hospitals
city: Southampton
country: United Kingdom
facility: Southampton University Hospital
Study officials:
References: