National Tunisian Registry of Valvulopathies (NATURE-VALVE)

Valvular Heart Disease Clinical Trial

— NATURE-VALVE  

Official title:

National Tunisian Registry of Valvulopathies (NATURE-VALVE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04509479
• Other study ID #: DAC-008-STCCCV
• Status: Completed
• Start date: July 6, 2020
• Est. completion date: July 30, 2022

Study information

• Verified date: August 2022
• Source: Dacima Consulting
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3637
• Est. completion date: July 30, 2022
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Diseases
• Heart Valve Diseases
• Valvular Heart Disease
• Valvular Insufficiency
• Valvular Stenosis

Intervention

Procedure:
• Valve replacement
Description of valve replacements

Locations

Country	Name	City	State
Tunisia	The Tunisian Society of Cardiology and CardioVascular Surgery	Tunis

Sponsors (2)

Lead Sponsor	Collaborator
Dacima Consulting	Tunisian Society of Cardiology and Cardiovascular Surgery

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Valvulopathies incidence	Number of subjects with valvular disease (mitral or aortic or tricuspid) and willing to participate at the study	at inclusion
Secondary	Major adverse cardiovascular events (MACE)	Number of patients with Major adverse cardiovascular events (MACE), including nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death.	at 6 months of follow-up