Heart Valve DiseaseCDSS-ValveNCT06392464
Validation of Naevia Medical in Valvulopathies
An observational study of Heart Valve Disease, run by Dilemma Solutions S.L. at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Heart Valve Disease
- What is being tested?
- Clinical decision support system (software)
- Type of treatment
- Medical device
- How many people
- 106 participants
- Where
- 1 siteSpain
- Study dates
- 27 Mar 2024to 24 Jan 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
Study population: Patients evaluated in the outpatient clinic affected by heart valve disease
Who may be able to join
- 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
Show all 10Show fewer
- aortic valve stenosis
- aortic insufficiency
- mitral valve stenosis
- mitral insufficiency (greater than moderate severity)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Complejo Hospitalario Universitario de Santiago de Compostela
Santiago de Compostela, 15701
About this study
Official title: Clinical Validation Study of Naevia Medical, a Clinical Decision Support System, in Heart Valve Disease
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.
Read the detailed 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.
- Conditions
- Heart Valve Disease
- Being tested
- Clinical decision support system (software)
- Keywords
- clinical decision support system, artificial intelligence, cdss
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Clinical decision support system (software) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Number of Inappropriate Recommendations
Number of inappropriate recommendations (that do not apply to the specific case)
Measured: 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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start27 Mar 2024
- Primary completion24 Jan 2025
- Study completion24 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart Valve DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dilemma Solutions S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06392464
- Sponsor's protocol ID
- 2024/104
- Acronym
- CDSS-Valve
- Status last verified
- Dec 2025
- First submitted
- 26 Apr 2024
- Last updated
- 31 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation Study of Naevia Medical, a Clinical Decision Support System, in Heart Valve Disease
- ClinicalTrials.gov ID
- NCT06392464
- Acronym / sponsor ID
- CDSS-Valve / 2024/104
- Conditions
- Heart Valve Disease
- Keywords
- clinical decision support system, artificial intelligence, cdss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Dilemma Solutions S.L.Industry (pharma, biotech, devices)
- Study start
- 27 Mar 2024 (actual)
- Primary completion
- 24 Jan 2025 (actual)
- Study completion
- 24 Jan 2025 (actual)
- First posted
- 30 Apr 2024 (actual)
- Results
- Posted 31 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with heart valve disease | – | Device: Clinical decision support system (software)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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients evaluated in the outpatient clinic affected by heart valve disease
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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.) | Device | Patients with heart valve disease |
Primary outcome
Number of Relevant Appropriate Recommendations
Time frame: 1 week
Number of relevant appropriate recommendations. Only high-level recommendations (class I and IIa) were included and evaluated in the study.
Number of Inappropriate Recommendations
Time frame: 1 week
Number of inappropriate recommendations (that do not apply to the specific case)
Number of Relevant Missing Recommendations
Time frame: 1 week
Number of relevant missing recommendations. Only high-level recommendations (class I and IIa) were included and evaluated in the study.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Official webpage of the productLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Valve Disease, run by Dilemma Solutions S.L. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Relevant Appropriate Recommendations (time frame: 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.