National Tunisian Registry of Cardiac Implantable Electronic Devices (NATURE-CIED)
August 14, 2023 updated by: Dacima Consulting
National Tunisian Registry of Cardiac Implantable Electronic Devices (NATURE-CIED)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
1518
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Tunis, Tunisia, 1053
- The Tunisian Society of Cardiology and CardioVascular Surgery
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients undergoing cardiac implantable electronic device procedure
Description
Inclusion Criteria:
- Patients originated from Tunisia
- Signed informed consent
- Patients undergoing a cardiac implantable electronic device procedure
Exclusion Criteria:
- Informed Consent not given
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
at inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
at 12 months of follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Sonia Chabrak, MD, Tunisian Society of Cardiology and Cardiovascular Surgery
- Study Director: Abdeddayem Haggui, MD, Tunisian Society of Cardiology and Cardiovascular Surgery
- Principal Investigator: Salma Krichène, MD, Tunisian Society of Cardiology and Cardiovascular Surgery
- Principal Investigator: Slim Kacem, MD, Tunisian Society of Cardiology and Cardiovascular Surgery
- Principal Investigator: Sonia Marrakchi, MD, Tunisian Society of Cardiology and Cardiovascular Surgery
- Principal Investigator: Emna Allouche, MD, Tunisian Society of Cardiology and Cardiovascular Surgery
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 18, 2021
Primary Completion (Actual)
August 15, 2023
Study Completion (Actual)
August 15, 2023
Study Registration Dates
First Submitted
April 30, 2022
First Submitted That Met QC Criteria
April 30, 2022
First Posted (Actual)
May 5, 2022
Study Record Updates
Last Update Posted (Actual)
August 15, 2023
Last Update Submitted That Met QC Criteria
August 14, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- DAC-012-NATURECIED
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.