Validation of Naevia Medical in Valvulopathies

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Heart Valve Diseases

Clinical Trial Details

NCT number	NCT06392464
Study type	Observational
Source	Dilemma Solutions S.L.
Contact	Lorenzo Monserrat, MD, PhD
Phone	+34680927110
Email	lorenzo.monserrat@naeviamedical.com
Status	Recruiting
Phase
Start date	March 27, 2024
Completion date	March 27, 2025

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Validation of Naevia Medical in Valvulopathies — CDSS-Valve

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms