Validation of Naevia Medical in Valvulopathies (CDSS-Valve)

April 26, 2024 updated by: Dilemma Solutions S.L.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

101

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Santiago de Compostela, Spain, 15701

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Patients evaluated in the outpatient clinic affected by heart valve disease

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical benefits of the CDSS compared to conventional management
Time Frame: 1 year
Evaluation of the number of appropriate and inappropriate recommendations during baseline measurement (conventional management) and after CDSS activation
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dilemma Solutions S.L.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2024

Primary Completion (Estimated)

September 27, 2024

Study Completion (Estimated)

March 27, 2025

Study Registration Dates

First Submitted

April 26, 2024

First Submitted That Met QC Criteria

April 26, 2024

First Posted (Actual)

April 30, 2024

Study Record Updates

Last Update Posted (Actual)

April 30, 2024

Last Update Submitted That Met QC Criteria

April 26, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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