Accepted for/Published in: JMIR Research Protocols
Date Submitted: Mar 24, 2023
Date Accepted: Oct 31, 2023
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Design and Rationale of the National Tunisian Registry of Cardiac implantable Electronic Device (NATURE-CIED)
ABSTRACT
Background:
In Tunisia, the number of cardiac implantable electronic devices is increasing owing to the increase in patient life expectancy and expanding indications. Despite their life-saving potential and a significant reduction in population morbidity and mortality, their increased numbers have been associated with the development of multiple acute and late complications related to vascular access, pockets, leads, or patient characteristics.
Objective:
The primary endpoint of this study was to determine the incidence, nature, and predictors of short- and medium-term (12-month) complications associated with implantable electronic devices. Secondary endpoints were to assess the demographic and epidemiological profiles of a Tunisian national cohort of consecutive patients receiving implanted electronic devices and the degree of adherence of Tunisian electrophysiologists to international guidelines for cardiac pacing and prevention of sudden cardiac death.
Methods:
The Tunisian National Registry of Cardiac Implantable Electronic Devices (NATURE-CIED) is a national, multicenter, prospectively monitored registry that includes consecutive patients who underwent primary CIED implantation, generator replacement, and/or system upgrade. Patients were enrolled between January 18, 2021, and February 18, 2022 at all Tunisian public and private CIED implantation centers that agreed to participate in the study. All enrolled patients entered a one-year follow-up period with four consecutive visits at 1, 3, 6, and 12 months after CIED implantation. The collected data is recorded electronically on the clinical suite platform: DACIMA Clinical Suite®.
Results:
The study started on January 18, 2021 and ended on February 18, 2023. During this period, we consecutively enrolled 1479 patients. Twenty-seven electrophysiologists participated in data collection. Investigators work in both the private and public sectors.
Conclusions:
This study will yield the largest contemporary longitudinal cohort of patients undergoing CIED implantation in Tunisia and would provide a valuableopportunityforreal-worldclinicalepidemiologywith insights into the uptake and outcomes of contemporary CIED management. Clinical Trial: NCT05361759
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