Validation of Naevia Medical in Valvulopathies

Heart Valve Diseases Clinical Trial

— CDSS-Valve  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06392464
• Other study ID #: 2024/104
• Status: Recruiting
• Start date: March 27, 2024
• Est. completion date: March 27, 2025

Study information

• Verified date: April 2024
• Source: Dilemma Solutions S.L.
• Contact: Lorenzo Monserrat, MD, PhD
• Phone: +34680927110
• Email: lorenzo.monserrat[@]naeviamedical.com
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 101
• Est. completion date: March 27, 2025
• Est. primary completion date: September 27, 2024
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Valve Diseases

Intervention

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.)

Locations

Country	Name	City	State
Spain	Complejo Hospitalario Universitario de Santiago de Compostela	Santiago de Compostela

Sponsors (1)

Lead Sponsor	Collaborator
Dilemma Solutions S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical benefits of the CDSS compared to conventional management	Evaluation of the number of appropriate and inappropriate recommendations during baseline measurement (conventional management) and after CDSS activation	1 year

External Links

•   Official webpage of the product