National Tunisian Registry of Cardiac Implantable Electronic Devices

Cardiac Implantable Electronic Devices Clinical Trial

— NATURE-CIED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05361759
• Other study ID #: DAC-012-NATURECIED
• Status: Completed
• Start date: January 18, 2021
• Est. completion date: August 15, 2023

Study information

• Verified date: August 2023
• Source: Dacima Consulting
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1518
• Est. completion date: August 15, 2023
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients originated from Tunisia
• Signed informed consent
• Patients undergoing a cardiac implantable electronic device procedure

Exclusion Criteria:

• Informed Consent not given

Related Conditions & MeSH terms

• Cardiac Implantable Electronic Devices

Intervention

Device:
• Cardiac Implantable Electronic Devices
Description of Cardiac Implantable Electronic Devices

Locations

Country	Name	City	State
Tunisia	The Tunisian Society of Cardiology and CardioVascular Surgery	Tunis

Sponsors (2)

Lead Sponsor	Collaborator
Dacima Consulting	Tunisian Society of Cardiology and Cardiovascular Surgery

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of patients undergoing cardiac implantable electronic devices in Tunisia	Number of subjects with heart disease (heart failure, rythm disorder) and willing to participate at the study and who are eligible for cardiac implantable electronic devices procedures	at inclusion
Secondary	Heart complication	Number of patients with cardiovascular event, including death, tamponade, pericarditis, heart failure, worsening of valvular disease, moving the right ventricular lead, compartment infection, phrenic stimulation, conductor breakage, or any other cardiovascular complication related to the cardiac implantable electronic device	at 12 months of follow-up

External Links

•   Tunisian Society of Cardiology and Cardiovascular Surgery Website