Clinical trial NCT06392464: Validation of Naevia Medical in Valvulopathies
Official title: Clinical Validation Study of Naevia Medical, a Clinical Decision Support System, in Heart Valve Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Valve Diseases
Keywords: clinical decision support system
artificial intelligence
cdss
Lead sponsor: Dilemma Solutions S.L.
Sponsor class: INDUSTRY
First posted: 2024-04-30
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients evaluated in the outpatient clinic affected by heart valve disease

Brief summary: The study aims to validate naevia medical, a knowledge-based clinical decision support system (CDSS), for clinical benefit and safety in cases of cardiac valvulopathies. Using a series of retrospective clinical cases of heart valve disease, the research will evaluate the number of appropriate and inappropriate recommendations during baseline measurement (conventional management) and after CDSS activation.

Detailed description: The objective of this study is to validate both the clinical benefit and safety of a knowledge-based clinical decision support system (CDSS), naevia medical, applied to clinical cases of cardiac valvulopathies.

naevia medical aims to bridge the gap between scientific evidence and medical practice by improving adherence to scientific recommendations.

The research aims to establish and verify that the naevia medical product is suitable for its intended purposes and provides the specified intended functionality as outlined by its manufacturer under normal conditions of use. It seeks to verify the clinical benefits of the product compared to conventional management by enhancing healthcare professionals' ability to provide a greater number of scientifically based recommendations tailored to each patient's specific situation. Additionally, the study aims to establish the clinical safety of the product by identifying potential undesirable side effects under normal usage conditions and evaluating whether these effects constitute acceptable risks in relation to the benefits provided.

To achieve these objectives, a clinical research study will be conducted to assess naevia medical's capacity to increase appropriate recommendations and decrease inappropriate recommendations received by patients with valvulopathy, compared to conventional management without support.

The study proposes a pre-test-post-test design with a randomly assigned group, utilizing a longitudinal approach with repeated measures and retrospective validation. Evaluation criteria will focus on the number of appropriate and inappropriate recommendations during baseline measurement (conventional management) and after CDSS activation, using a series of retrospective clinical cases of heart valve disease.

Eligibility criteria: Inclusion Criteria:

* Patients randomly selected from those presented during the year 2022 in medical-surgical sessions, with a primary diagnosis of:

  * aortic valve stenosis
  * aortic insufficiency
  * mitral valve stenosis
  * mitral insufficiency (greater than moderate severity)..
* Patients randomly selected from valvulopathy clinic records attended during the year 2022, with a primary diagnosis of

  * aortic valve stenosis
  * aortic insufficiency
  * mitral valve stenosis
  * mitral insufficiency (greater than moderate severity)

Exclusion Criteria:

* Subjects under 18 years old.
* Inability to anonymize the case.
* Clinical cases of valvulopathies in which a complex congenital heart disease coexists.
* Clinical cases that do not meet the minimum data set necessary for decision-making.
* Clinical cases with a primary diagnosis other than valvulopathy.
* Presence of bacterial endocarditis

Primary outcomes:
measure: Clinical benefits of the CDSS compared to conventional management
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago de Compostela
Study officials:
References: