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

August 19, 2022 updated by: Dacima Consulting
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

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3637

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Time Frame: at inclusion
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)
Time Frame: at 6 months of follow-up
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

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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