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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical decision support system (software) | Device | 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.) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Relevant Appropriate Recommendations | Number of relevant appropriate recommendations. Only high-level recommendations (class I and IIa) were included and evaluated in the study. | 1 week |
| Number of Inappropriate Recommendations | Number of inappropriate recommendations (that do not apply to the specific case) | 1 week |
| Number of Relevant Missing Recommendations | Number of relevant missing recommendations. Only high-level recommendations (class I and IIa) were included and evaluated in the study. | 1 week |
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Inclusion Criteria:
Patients randomly selected from those presented during the year 2022 in medical-surgical sessions, with a primary diagnosis of:
Patients randomly selected from valvulopathy clinic records attended during the year 2022, with a primary diagnosis of
Exclusion Criteria:
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Patients evaluated in the outpatient clinic affected by heart valve disease
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complejo Hospitalario Universitario de Santiago de Compostela | Santiago de Compostela | 15701 | Spain |
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| Label | URL |
|---|---|
| Official webpage of the product | View source |
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The same group of 106 cases was evaluated before and after the CDSS activation.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. The clinical management of the included cases was retrospectively evaluated by a panel of 3 experts with access to the most updated guidelines, without activating the CDSS. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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106 clinical cases of aortic stenosis, aortic insufficiency, mitral stenosis, and mitral insufficiency were selected with stratified random sampling. The conventional clinical management was retrospectively evaluated by three expert cardiologists using updated guidelines.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Relevant Appropriate Recommendations | Number of relevant appropriate recommendations. Only high-level recommendations (class I and IIa) were included and evaluated in the study. | Posted | Mean | Standard Deviation | Recommendations | 1 week |
|
N/A (retrospective evaluation)
This study is a retrospective evaluation of historical cases by an expert panel assessment. The evaluation was performed with and without the activation of the CDSS. The clinical recommendations provided with conventional management and after the CDSS activation were counted and evaluated, but no new interventions were applied. Therefore, no adverse events were prospectively collected and the number of participants 'at risk' for adverse-event monitoring is 0.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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The main limitation of the present study is its retrospective design, which does not allow to evaluate naevia's impact on clinical decision making in real life. This aspect will be addressed in further prospective studies.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Violeta Gonzalez Salvado | Complejo Hospitalario Universitario de Santiago de Compostela, Spain | +34981955913 | vgonzalezsalvado@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 3, 2025 | Jul 2, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 3, 2025 | Sep 1, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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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.
The clinical management of the included cases was retrospectively evaluated by a panel of 3 experts with access to the most updated guidelines, without activating the CDSS.
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| Primary | Number of Inappropriate Recommendations | Number of inappropriate recommendations (that do not apply to the specific case) | Posted | Mean | Standard Deviation | Recommendations | 1 week |
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| Primary | Number of Relevant Missing Recommendations | Number of relevant missing recommendations. Only high-level recommendations (class I and IIa) were included and evaluated in the study. | Posted | Mean | Standard Deviation | Recommendations | 1 week |
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