National Tunisian Registry of Cardiac Implantable Electronic Devices

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05361759

Acronym

NATURE-CIED

Enrollment

1518

Registered

2022-05-05

Start date

2021-01-18

Completion date

2023-08-15

Last updated

2023-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Implantable Electronic Devices

Keywords

Cardiac Implantable Electronic Devices, Heart, Pacemaker, Implantable Cardioverter Defibrillator, Cardiac Loop Recorders, Biventricular Pacemakers, Heart rhythm disorder

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.

Interventions

DEVICECardiac Implantable Electronic Devices

Description of Cardiac Implantable Electronic Devices

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Informed Consent not given

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Tunisia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026