## Protocol Section
### Identification Module
**NCT ID:** NCT04509479

**Acronym:** NATURE-VALVE

**Brief Title:** National Tunisian Registry of Valvulopathies (NATURE-VALVE)

**Official Title:** National Tunisian Registry of Valvulopathies (NATURE-VALVE)

#### Organization Study ID Info
**ID:** DAC-008-STCCCV
#### Organization
**Class:** OTHER
**Full Name:** Dacima Consulting
### Status Module
#### Completion Date
**Date:** 2022-07-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-08-22

**Type:** ACTUAL

**Last Update Submit Date:** 2022-08-19

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-03-31

**Type:** ACTUAL

#### Start Date
**Date:** 2020-07-06

**Type:** ACTUAL

**Status Verified Date:** 2022-08

#### Study First Post Date
**Date:** 2020-08-12
**Type:** ACTUAL
**Study First Submit Date:** 2020-08-09
**Study First Submit QC Date:** 2020-08-09
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Tunisian Society of Cardiology and Cardiovascular Surgery

#### Lead Sponsor

**Class:** OTHER

**Name:** Dacima Consulting

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Valvular Heart Disease

- Valvular Stenosis

- Valvular Insufficiency

**Keywords:**

- Valvular

- Heart

- Aortic

- Mitral

- Tricuspid

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 3637

**Type:** ACTUAL

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 6 Months

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** Description of valve replacements

**Name:** Valve replacement

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Valvulopathies incidence

**Time Frame:** at inclusion

#### Secondary Outcomes

**Description:** Number of patients with Major adverse cardiovascular events (MACE), including nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death.

**Measure:** Major adverse cardiovascular events (MACE)

**Time Frame:** at 6 months of follow-up

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients with valvular disease

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Tunis

**Country:** Tunisia

**Facility:** The Tunisian Society of Cardiology and CardioVascular Surgery

**Zip:** 1053

#### Overall Officials

**Official 1:**

**Affiliation:** Tunisian Society of Cardiology and Cardiovascular Surgery

**Name:** Fathia Mghaieth, MD

**Role:** STUDY_CHAIR

**Official 2:**

**Affiliation:** Tunisian Society of Cardiology and Cardiovascular Surgery

**Name:** Lilia Zakhama, MD

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M9419

- Name: Heart Diseases

- Relevance: HIGH

- As Found: Heart Disease

- ID: M6475

- Name: Constriction, Pathologic

- Relevance: LOW

- As Found: Unknown

- ID: M9437

- Name: Heart Valve Diseases

- Relevance: HIGH

- As Found: Valvular Heart Disease

### Condition Browse Module - Meshes

- ID: D000006331

- Term: Heart Diseases

- ID: D000006349

- Term: Heart Valve Diseases

### Misc Info Module

- Version Holder: 2024-05-24
