Validation of Naevia Medical in Valvulopathies

NCT06392464 | Completed Results

• 1 other identifier: 2024/104
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Valve Disease

Keywords

clinical decision support system; artificial intelligence; cdss

Outcome Measures

Primary Outcomes (3)

• Number of Relevant Appropriate Recommendations

  Number of relevant appropriate recommendations. Only high-level recommendations (class I and IIa) were included and evaluated in the study.

  1 week

• Number of Inappropriate Recommendations

  Number of inappropriate recommendations (that do not apply to the specific case)

  1 week

• Number of Relevant Missing Recommendations

  Number of relevant missing recommendations. Only high-level recommendations (class I and IIa) were included and evaluated in the study.

  1 week

Study Arms (1)

Patients with heart valve disease

The same group of patients is evaluated with a pre-test-post-test design with a randomly assigned group, utilizing a longitudinal approach with repeated measures and retrospective validation.

Device: Clinical decision support system (software)

Interventions

Clinical decision support system (software) DEVICE

Use of a clinical decision support system. "Naevia Medical" is clinical decision support software (CDSS) that, based on clinical input data (patient history, symptoms, complementary test data, etc.) from adult patients with heart disease, provides healthcare professionals with prioritized, justified, and referenced recommendations and knowledge-related suggestions related to diagnosis, prognosis, and/or treatment (recommended tests, medications, alerts, etc.)

Patients with heart valve disease

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients evaluated in the outpatient clinic affected by heart valve disease

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Dilemma Solutions S.L.: lead

Study Sites (1)

Complejo Hospitalario Universitario de Santiago de Compostela

Santiago de Compostela, 15701, Spain

Location

Related Links

• Official webpage of the product

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

The main limitation of the present study is its retrospective design, which does not allow to evaluate naevia's impact on clinical decision making in real life. This aspect will be addressed in further prospective studies.

Results Point of Contact

• Title: Violeta Gonzalez Salvado
• Organization: Complejo Hospitalario Universitario de Santiago de Compostela, Spain

vgonzalezsalvado@gmail.com

+34981955913

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: April 30, 2024
• Study Start: March 27, 2024
• Primary Completion: January 24, 2025
• Study Completion: January 24, 2025
• Last Updated: December 31, 2025
• Results First Posted: December 31, 2025

Record last verified: 2025-12

Locations

ES (1)