National Tunisian Registry of Valvulopathies (NATURE-VALVE) | NCT04509479

Studies
National Tunisian Registry of Valvulopathies (NATURE-VALVE)

NCT04509479

Sponsor

Dacima Consulting

Status

Completed

Last Update Posted

Aug 22, 2022Actual

Enrollment

3,637Actual

Phase

Not provided

Conditions

Valvular Heart Disease
Valvular Stenosis
Valvular Insufficiency

Interventions

Valve replacement

Countries

Tunisia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 6, 2020Actual

Primary Completion Date

Mar 31, 2021Actual

Completion Date

Jul 30, 2022Actual

First Submitted Date

Aug 9, 2020

First Submission Date that Met QC Criteria

Aug 9, 2020

First Posted Date

Aug 12, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 19, 2022

Last Update Posted Date

Aug 22, 2022Actual

Name	Class
Tunisian Society of Cardiology and Cardiovascular Surgery	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,637Actual

Name	Type	Description	Arm Group Labels	Other Names
Valve replacement	Procedure	Description of valve replacements

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Valvulopathies incidence	Number of subjects with valvular disease (mitral or aortic or tricuspid) and willing to participate at the study	at inclusion

Secondary Outcomes

Measure	Description	Time Frame
Major adverse cardiovascular events (MACE)	Number of patients with Major adverse cardiovascular events (MACE), including nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death.	at 6 months of follow-up

Other Outcomes

Not provided

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with valvular disease

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fathia Mghaieth, MD	Tunisian Society of Cardiology and Cardiovascular Surgery	Study Chair
Lilia Zakhama, MD	Tunisian Society of Cardiology and Cardiovascular Surgery	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Tunisian Society of Cardiology and CardioVascular Surgery		Tunis		1053	Tunisia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006349	Heart Valve Diseases

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D065467	Transcatheter Aortic Valve Replacement

Ancestor Terms

ID	Term
D019918	Heart Valve Prosthesis Implantation
D006348	Cardiac Surgical Procedures
D013504	Cardiovascular Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided