National Tunisian Registry of Valvulopathies (NATURE-VALVE) (NATURE-VALVE)

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 Overview

• Status: Completed
• Conditions: Valvular Heart Disease; Valvular Stenosis; Valvular Insufficiency
• Intervention / Treatment: Procedure: Valve replacement

• Study Type: Observational
• Enrollment (Actual): 3637

Contacts and Locations

Study Locations

• Tunisia
  • Tunis, Tunisia, 1053
    • The Tunisian Society of Cardiology and CardioVascular Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with valvular disease

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Dacima Consulting
• Collaborators: Tunisian Society of Cardiology and Cardiovascular Surgery
• Investigators: Study Chair: Fathia Mghaieth, MD, Tunisian Society of Cardiology and Cardiovascular Surgery; Study Chair: Lilia Zakhama, MD, Tunisian Society of Cardiology and Cardiovascular Surgery

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2020
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): July 30, 2022

Study Registration Dates

• First Submitted: August 9, 2020
• First Submitted That Met QC Criteria: August 9, 2020
• First Posted (Actual): August 12, 2020

Study Record Updates

• Last Update Posted (Actual): August 22, 2022
• Last Update Submitted That Met QC Criteria: August 19, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Heart; Mitral; Valvular; Aortic; Tricuspid
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases
• Other Study ID Numbers: DAC-008-STCCCV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No