National Tunisian Registry of Cardiac Implantable Electronic Devices

Completed

• Conditions: Cardiac Implantable Electronic Devices

• Registration Number: NCT05361759
• Lead Sponsor: Dacima Consulting

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-18
• Study First Submitted: 2022-04-30
• Study First Submitted QC: 2022-04-30
• Study First Posted: 2022-05-05
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-14
• Primary Completion: 2023-08-15
• Study Completion: 2023-08-15
• Last Update Posted: 2023-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1518

Inclusion Criteria

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

Exclusion Criteria

• Informed Consent not given

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of patients undergoing cardiac implantable electronic devices in Tunisia	at inclusion	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

Secondary Outcome Measures

Name	Time	Method
Heart complication	at 12 months of follow-up	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

Trial Locations

Locations (1)

The Tunisian Society of Cardiology and CardioVascular Surgery; 🇹🇳 Tunis, Tunisia