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National Tunisian Registry of Valvulopathies (NATURE-VALVE)

NCT04509479 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3637

Last updated 2022-08-22

No results posted yet for this study

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

Interventions

PROCEDURE

Valve replacement

Description of valve replacements

Sponsors & Collaborators

  • Tunisian Society of Cardiology and Cardiovascular Surgery

    collaborator OTHER

  • Dacima Consulting

    lead OTHER

Principal Investigators

  • Fathia Mghaieth, MD · Tunisian Society of Cardiology and Cardiovascular Surgery

  • Lilia Zakhama, MD · Tunisian Society of Cardiology and Cardiovascular Surgery

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-06
Primary Completion
2021-03-31
Completion
2022-07-30

Countries

  • Tunisia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04509479 on ClinicalTrials.gov