Acorai MLG Study (Machine Learning Generalisation)
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 23-006191
NCT ID: NCT05835024
About this study
This clinical investigation is part of the development of a non-invasive monitoring system for the estimation of intracardiac hemodynamic parameters. In this clinical investigation data will be generated which will be used to train machine learning models.
Assess the feasibility of training machine learning models to accurately estimate intracardiac hemodynamic parameters using data collected from the ASDC System 1.0 in patients undergoing a right heart catheterization.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 6/7/23. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Rohan Goswami, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available