Validation of a clinical decision support system for heart valve diseases
Clinical Validation Study of Naevia Medical, a Clinical Decision Support System, in Heart Valve Disease
This study is testing a new decision support system to see if it helps doctors make better and safer choices for patients with heart valve diseases.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 101 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Dilemma Solutions S.L. Industry-sponsored |
| Locations | 1 site (Santiago de Compostela) |
| Trial ID | NCT06392464 on ClinicalTrials.gov |
What this trial studies
This study aims to validate the naevia medical clinical decision support system (CDSS) for its clinical benefit and safety in managing cardiac valvulopathies. It will analyze retrospective clinical cases to compare the number of appropriate and inappropriate recommendations made during conventional management versus after the activation of the CDSS. The research seeks to enhance healthcare professionals' adherence to scientific recommendations tailored to individual patient situations while assessing the safety of the system. A pre-test-post-test design will be utilized with a longitudinal approach to evaluate the effectiveness of the CDSS.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with aortic or mitral valve diseases of greater than moderate severity.
Not a fit: Patients under 18 years old or those with complex congenital heart diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the quality of care for patients with heart valve diseases by providing more accurate and tailored treatment recommendations.
How similar studies have performed: Other studies have shown promise in using clinical decision support systems for improving patient outcomes, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Santiago de Compostela
- Complejo Hospitalario Universitario de Santiago de Compostela — Santiago de Compostela, Spain (Recruiting)
Study contacts
- Study coordinator: Lorenzo Monserrat, MD, PhD
- Email: lorenzo.monserrat@naeviamedical.com
- Phone: +34680927110
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.