NCT05361759

National Tunisian Registry of Cardiac Implantable Electronic Devices

National Tunisian Registry of Cardiac Implantable Electronic Devices (NATURE-CIED)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,518 (actual)
• Sponsor: Dacima Consulting · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The National Tunisian Registry of Cardiac Implantable Electronic Devices is an observational, prospective and multicenter study aiming to assess the epidemiological, clinical and therapeutic profile of cardiac implantable electronic Devices in Tunisia. Cardiologists from both sectors (public and private) are participating in the study, with 26 investigational centers. Data is 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

• Cardiac Implantable Electronic Devices

Interventions

Type	Name	Description
DEVICE	Cardiac Implantable Electronic Devices	Description of Cardiac Implantable Electronic Devices

Timeline

• Start date: 2021-01-18
• Primary completion: 2023-08-15
• Completion: 2023-08-15
• First posted: 2022-05-05
• Last updated: 2023-08-15

Locations

1 site across 1 country: Tunisia