National Tunisian Registry of Valvulopathies (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.

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Key information

Conditions

Valvular Heart Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Valvular Insufficiency Valvular Stenosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Tunisian Society of Cardiology and CardioVascular Surgery

Tunis, 1053, Tunisia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Congenital valve diseases not including bicuspid aortic valve
Isolated pulmonary valvulopathies

Treatment and study plan

Valve replacement

Procedure

Description of valve replacements

Primary outcomes

Valvulopathies incidence

Time frame: at inclusion

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

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Dacima Consulting

Other

Collaborators

Tunisian Society of Cardiology and Cardiovascular Surgery

Registry information

Acronym: NATURE-VALVE

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2022
First posted: Aug 12, 2020
Registry last updated: Aug 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed