National Tunisian Registry of Valvulopathies (NATURE-VALVE)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04509479

Acronym

NATURE-VALVE

Enrollment

3637

Registered

2020-08-12

Start date

2020-07-06

Completion date

2022-07-30

Last updated

2022-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Valvular Heart Disease, Valvular Insufficiency, Valvular Stenosis

Keywords

Valvular, Heart, Aortic, Mitral, Tricuspid

Brief summary

The National Tunisian Registry of Valvulopathies is an observational, prospective and multicenter study aiming to assess the epidemiological, clinical and therapeutic profile of valve disease in tunisian departments of cardiology. Cardiologists from both sectors (public and private) are participating in the study, with 37 investigational centers. Data will be captured electronically by DACIMA Clinical Suite, according to FDA 21 CFR part 11 (Food and Drug Administration 21 Code of Federal Regulations part 11), HIPAA (Health Insurance Portability and Accountability Act) & ICH (International Conference on Harmonisation) requirements.

Interventions

PROCEDUREValve replacement

Description of valve replacements

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients originated from Tunisia * Signed informed consent * Patients with at least one of the following conditions : 1. moderate to severe native mitral and / or aortic and / or tricuspid native valve disease 2. and / or a history of a previous percutaneous or surgical valve intervention 3. and / or a history of infectious endocarditis

Exclusion criteria

* Congenital valve diseases not including bicuspid aortic valve * Isolated pulmonary valvulopathies

Design outcomes

Primary

Measure	Time frame	Description
Valvulopathies incidence	at inclusion	Number of subjects with valvular disease (mitral or aortic or tricuspid) and willing to participate at the study

Secondary

Measure	Time frame	Description
Major adverse cardiovascular events (MACE)	at 6 months of follow-up	Number of patients with Major adverse cardiovascular events (MACE), including nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death.

Countries

Tunisia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026