NCT06392464

Validation of Naevia Medical in Valvulopathies

Clinical Validation Study of Naevia Medical, a Clinical Decision Support System, in Heart Valve Disease

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 106 (actual)
• Sponsor: Dilemma Solutions S.L. · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: —

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.

Conditions

• Heart Valve Disease

Interventions

Type	Name	Description
DEVICE	Clinical decision support system (software)	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.)

Timeline

• Start date: 2024-03-27
• Primary completion: 2025-01-24
• Completion: 2025-01-24
• First posted: 2024-04-30
• Last updated: 2025-12-31
• Results posted: 2025-12-31

Locations

1 site across 1 country: Spain