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Completed

NCT Number: NCT05361759

National Tunisian Registry of Cardiac Implantable Electronic Devices

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.

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Key information

Conditions

Cardiac Implantable Electronic Devices

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Tunisian Society of Cardiology and CardioVascular Surgery

Tunis, 1053, Tunisia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Informed Consent not given

Treatment and study plan

Cardiac Implantable Electronic Devices

Device

Description of Cardiac Implantable Electronic Devices

Primary outcomes

  1. Incidence of patients undergoing cardiac implantable electronic devices in Tunisia

    Time frame: 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 outcomes

  1. Heart complication

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Dacima Consulting

Other

Collaborators

  • Tunisian Society of Cardiology and Cardiovascular Surgery

Registry information

Official study title

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

Acronym: NATURE-CIED

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 5, 2022
Registry last updated
Aug 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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