National Tunisian Registry of Valvulopathies (NATURE-VALVE)

Dacima Consulting3,637 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

3,637

Conditions

Valvular Heart Disease Valvular Stenosis Valvular Insufficiency

Interventions

Valve replacement

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Valvulopathies incidence

Number of subjects with valvular disease (mitral or aortic or tricuspid) and willing to participate at the study

Time frame: at inclusion

Secondary Outcomes

Major adverse cardiovascular events (MACE)

Number of patients with Major adverse cardiovascular events (MACE), including nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death.

Time frame: at 6 months of follow-up