Validation of Naevia Medical in Valvulopathies (NCT06392464) | Clinical Trial Compass
CompletedNot Applicable
Validation of Naevia Medical in Valvulopathies
Spain106 participantsStarted 2024-03-27
Plain-language 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 recommendations during baseline measurement (conventional management) and after CDSS activation.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.