National Tunisian Registry of Valvulopathies (NATURE-VALVE)

DACIMA

Status: Completed

Conditions: Valvular Stenosis; Valvular Heart Disease; Valvular Insufficiency

Treatments: Procedure: Valve replacement

Study type: Observational

Funder types: Other

Identifiers

NCT04509479

DAC-008-STCCCV

Details and patient eligibility

About

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.

Enrollment: 3,637 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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