Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
101 participants
OBSERVATIONAL
2024-03-27
2025-03-27
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Patients with heart valve disease
The same group of patients is evaluated with a pre-test-post-test design with a randomly assigned group, utilizing a longitudinal approach with repeated measures and retrospective validation.
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.)
Interventions
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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.)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
100 Years
ALL
No
Sponsors
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Dilemma Solutions S.L.
INDUSTRY
Responsible Party
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Locations
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Complejo Hospitalario Universitario de Santiago de Compostela
Santiago de Compostela, , Spain
Countries
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Central Contacts
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Facility Contacts
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Carlos Peña, MD, PhD
Role: primary
Related Links
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Official webpage of the product
Other Identifiers
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2024/104
Identifier Type: -
Identifier Source: org_study_id