National Tunisian Registry of Valvulopathies (NATURE-VALVE)

Completed

• Conditions: Valvular Stenosis; Valvular Insufficiency; Valvular Heart Disease

• Registration Number: NCT04509479
• Lead Sponsor: Dacima Consulting

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-06
• Study First Submitted: 2020-08-09
• Study First Submitted QC: 2020-08-09
• Study First Posted: 2020-08-12
• Primary Completion: 2021-03-31
• Study Completion: 2022-07-30
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-19
• Last Update Posted: 2022-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3637

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The Tunisian Society of Cardiology and CardioVascular Surgery; 🇹🇳 Tunis, Tunisia