National Tunisian Registry of Valvulopathies (NATURE-VALVE)

NCT04509479 | Completed

• 1 other identifier: DAC-008-STCCCV
• Study Type: observational
• Target: 3,637
• Locations: 1 country
• Sites: 1

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.

Conditions

Valvular Heart Disease; Valvular Stenosis; Valvular Insufficiency

Keywords

Valvular; Heart; Aortic; Mitral; Tricuspid

Outcome Measures

Primary Outcomes (1)

• Valvulopathies incidence

  Number of subjects with valvular disease (mitral or aortic or tricuspid) and willing to participate at the study

  at inclusion

Secondary Outcomes (1)

• Major adverse cardiovascular events (MACE)

  at 6 months of follow-up

Interventions

Valve replacement PROCEDURE

Description of valve replacements

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with valvular disease

You may qualify if:

• Patients originated from Tunisia
• Signed informed consent
• Patients with at least one of the following conditions :
• moderate to severe native mitral and / or aortic and / or tricuspid native valve disease
• and / or a history of a previous percutaneous or surgical valve intervention
• and / or a history of infectious endocarditis

You may not qualify if:

• Congenital valve diseases not including bicuspid aortic valve
• Isolated pulmonary valvulopathies

Sponsors & Collaborators

• Dacima Consulting: lead
• Tunisian Society of Cardiology and Cardiovascular Surgery: collaborator

Study Sites (1)

The Tunisian Society of Cardiology and CardioVascular Surgery

Tunis, 1053, Tunisia

Location

MeSH Terms

Conditions

Heart Valve Diseases

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Fathia Mghaieth, MD

  Tunisian Society of Cardiology and Cardiovascular Surgery

  STUDY CHAIR

• Lilia Zakhama, MD

  Tunisian Society of Cardiology and Cardiovascular Surgery

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2020
• First Posted: August 12, 2020
• Study Start: July 6, 2020
• Primary Completion: March 31, 2021
• Study Completion: July 30, 2022
• Last Updated: August 22, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)