N/A
N=106
Validation of Naevia Medical in Valvulopathies
Heart Valve Disease
Bottom Line
View on ClinicalTrials.gov: NCT06392464 ↗Enrolled (actual)
106
Serious AEs
—
Results posted
Dec 2025
Primary outcome: Primary: Number of Relevant Appropriate Recommendations — 2.35; 6.20 Recommendations
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Clinical decision support system (software) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dilemma Solutions S.L.
- Primary completion
- Jan 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Relevant Appropriate Recommendations |
2.35; 6.20 | — |
| PRIMARY Number of Inappropriate Recommendations |
0.29; 0.07 | — |
| PRIMARY Number of Relevant Missing Recommendations |
3.80; 0.49 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT06392464). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.