Trials / Completed
CompletedNCT04509479
National Tunisian Registry of Valvulopathies (NATURE-VALVE)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 3,637 (actual)
- Sponsor
- Dacima Consulting · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Valve replacement | Description of valve replacements |
Timeline
- Start date
- 2020-07-06
- Primary completion
- 2021-03-31
- Completion
- 2022-07-30
- First posted
- 2020-08-12
- Last updated
- 2022-08-22
Locations
1 site across 1 country: Tunisia
Source: ClinicalTrials.gov record NCT04509479. Inclusion in this directory is not an endorsement.