Acorai MLG Study (Machine Learning Generalisation)
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ClinicalTrials.gov Identifier: NCT05835024 |
Recruitment Status :
Recruiting
First Posted : April 28, 2023
Last Update Posted : August 29, 2023
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Tracking Information | |||||
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First Submitted Date | April 18, 2023 | ||||
First Posted Date | April 28, 2023 | ||||
Last Update Posted Date | August 29, 2023 | ||||
Actual Study Start Date | August 15, 2023 | ||||
Estimated Primary Completion Date | December 30, 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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.
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Acorai MLG Study (Machine Learning Generalisation) | ||||
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 | ||||
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. |
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Detailed Description | Not Provided | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Cross-Sectional |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Patients enrolled for a right heart catheterization procedure as part of their standard of care. | ||||
Condition | Heart Failure | ||||
Intervention | Device: Acorai Sensor Data Collection (ASDC) system 1.0
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. |
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Study Groups/Cohorts | Participants
Patients enrolled for a right heart catheterization procedure as part of their standard of care.
Intervention: Device: Acorai Sensor Data Collection (ASDC) system 1.0
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
1214 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | December 30, 2023 | ||||
Estimated Primary Completion Date | December 30, 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts | |||||
Listed Location Countries | United Kingdom | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT05835024 | ||||
Other Study ID Numbers | ASDC-1 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||
Current Responsible Party | Acorai AB | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor | Acorai AB | ||||
Original Study Sponsor | Same as current | ||||
Collaborators | Not Provided | ||||
Investigators | Not Provided | ||||
PRS Account | Acorai AB | ||||
Verification Date | August 2023 |