Trial Outcomes & Findings for Validation of Naevia Medical in Valvulopathies (NCT NCT06392464)

NCT ID: NCT06392464

Last Updated: 2025-12-31

Results Overview

Number of relevant appropriate recommendations. Only high-level recommendations (class I and IIa) were included and evaluated in the study.

• Recruitment status: COMPLETED
• Target enrollment: 106 participants
• Primary outcome timeframe: 1 week
• Results posted on: 2025-12-31

Participant Flow

The same group of 106 cases was evaluated before and after the CDSS activation.

Participant milestones

Measure	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.
Overall Study STARTED	106
Overall Study Pre-test	106
Overall Study Post-test	106
Overall Study COMPLETED	106
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Patients With Heart Valve Disease n=106 Participants 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.
Age, Continuous	73.35 Years n=106 Participants
Sex: Female, Male Female	42 Participants n=106 Participants
Sex: Female, Male Male	64 Participants n=106 Participants

PRIMARY outcome

Timeframe: 1 week

Number of relevant appropriate recommendations. Only high-level recommendations (class I and IIa) were included and evaluated in the study.

Outcome measures

Measure	Patients with heart valve disease (pre-test) n=105 Participants 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.	Patients with heart valve disease (post-test) n=105 Participants 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.
Number of Relevant Appropriate Recommendations	2.35 Recommendations Standard Deviation 1.97	6.20 Recommendations Standard Deviation 2.57

PRIMARY outcome

Timeframe: 1 week

Number of inappropriate recommendations (that do not apply to the specific case)

Outcome measures

Measure	Patients with heart valve disease (pre-test) n=105 Participants 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.	Patients with heart valve disease (post-test) n=105 Participants 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.
Number of Inappropriate Recommendations	0.29 Recommendations Standard Deviation 0.60	0.07 Recommendations Standard Deviation 0.29

PRIMARY outcome

Timeframe: 1 week

Number of relevant missing recommendations. Only high-level recommendations (class I and IIa) were included and evaluated in the study.

Outcome measures

Measure	Patients with heart valve disease (pre-test) n=105 Participants 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.	Patients with heart valve disease (post-test) n=105 Participants 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.
Number of Relevant Missing Recommendations	3.80 Recommendations Standard Deviation 2.27	0.49 Recommendations Standard Deviation 0.67

Adverse Events

Patients With Heart Valve Disease

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Violeta Gonzalez Salvado

Complejo Hospitalario Universitario de Santiago de Compostela, Spain

Phone: +34981955913

Email: vgonzalezsalvado@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place