Validation of Naevia Medical in Valvulopathies

Last updated: April 26, 2024
Sponsor: Dilemma Solutions S.L.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Clinical decision support system (software)

Clinical Study ID

NCT06392464
2024/104
  • Ages 18-100
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients randomly selected from those presented during the year 2022 inmedical-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

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

Study Design

Total Participants: 101
Treatment Group(s): 1
Primary Treatment: Clinical decision support system (software)
Phase:
Study Start date:
March 27, 2024
Estimated Completion Date:
March 27, 2025

Study 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.

Connect with a study center

  • Complejo Hospitalario Universitario de Santiago de Compostela

    Santiago de Compostela, 15701
    Spain

    Active - Recruiting

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