Cardiac Implantable Electronic DevicesNATURE-CIEDNCT05361759
National Tunisian Registry of Cardiac Implantable Electronic Devices
An observational study of Cardiac Implantable Electronic Devices, run by Dacima Consulting at 1 site in Tunisia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Implantable Electronic Devices
- What is being tested?
- Cardiac Implantable Electronic Devices
- Type of treatment
- Medical device
- How many people
- 1,518 participants
- Where
- 1 siteTunisia
- Study dates
- 18 Jan 2021to 15 Aug 2023
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing cardiac implantable electronic device procedure
Who may be able to join
- Patients originated from Tunisia
- Signed informed consent
- Patients undergoing a cardiac implantable electronic device procedure
Who cannot join
- Informed Consent not given
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
The Tunisian Society of Cardiology and CardioVascular Surgery
Tunis, 1053
About this study
Official title: 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.
- Conditions
- Cardiac Implantable Electronic Devices
- Being tested
- Cardiac Implantable Electronic Devices
- Keywords
- Cardiac Implantable Electronic Devices, Heart, Pacemaker, Implantable Cardioverter Defibrillator, Cardiac Loop Recorders, Biventricular Pacemakers, Heart rhythm disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Implantable Electronic DevicesDevice
Description of Cardiac Implantable Electronic Devices
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of patients undergoing cardiac implantable electronic devices in Tunisia
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
Measured: at inclusion
Secondary outcomes (1)
Heart complication
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
Measured: at 12 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start18 Jan 2021
- Primary completion15 Aug 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Implantable Electronic DevicesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,518 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Dacima Consulting
- Sponsor type
- University, hospital or other
- Collaborators
- Tunisian Society of Cardiology and Cardiovascular Surgery
- Responsible party
- Sponsor
- Investigators
- Sonia Chabrak, MD, Study chair, Tunisian Society of Cardiology and Cardiovascular SurgeryAbdeddayem Haggui, MD, Study director, Tunisian Society of Cardiology and Cardiovascular SurgerySalma Krichène, MD, Principal investigator, Tunisian Society of Cardiology and Cardiovascular SurgerySlim Kacem, MD, Principal investigator, Tunisian Society of Cardiology and Cardiovascular SurgerySonia Marrakchi, MD, Principal investigator, Tunisian Society of Cardiology and Cardiovascular SurgeryEmna Allouche, MD, Principal investigator, Tunisian Society of Cardiology and Cardiovascular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05361759
- Sponsor's protocol ID
- DAC-012-NATURECIED
- Acronym
- NATURE-CIED
- Status last verified
- Aug 2023
- First submitted
- 30 Apr 2022
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chabrak S, Haggui A, Allouche E, Ouali S, Ben Halima A, Kacem S, Krichen S, Marrakchi S, Fehri W, Mourali MS, Jabbari Z, Ben Halima M, Neffati E, Heraiech A, Slim M, Kachboura S, Gamra H, Hassine M, Kraiem S, Kammoun S, Bezdah L, Jridi G, Bouraoui H, Kammoun S, Hammami R, Chettaoui R, Ben Ameur Y, Azaiez F, Tlili R, Battikh K, Ben Slima H, Chrigui R, Fazaa S, Sanaa I, Ellouz Y, Mosrati M, Milouchi S, Jarmouni S, Ayadi W, Akrout M, Razgallah R, Neffati W, Drissa M, Charfeddine S, Abdessalem S, Abid L, Zakhama L. National Tunisian Study of Cardiac Implantable Electronic Devices: Design and Protocol for a Nationwide Multicenter Prospective Observational Study. JMIR Res Protoc. 2024 Apr 8;13:e47525. doi: 10.2196/47525.
PubMed 38588529
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Tunisian Registry of Cardiac Implantable Electronic Devices (NATURE-CIED)
- ClinicalTrials.gov ID
- NCT05361759
- Acronym / sponsor ID
- NATURE-CIED / DAC-012-NATURECIED
- Conditions
- Cardiac Implantable Electronic Devices
- Keywords
- Cardiac Implantable Electronic Devices, Heart, Pacemaker, Implantable Cardioverter Defibrillator, Cardiac Loop Recorders, Biventricular Pacemakers, Heart rhythm disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,518 participants (actual)
- Lead sponsor
- Dacima ConsultingUniversity, hospital or other
- Collaborators
- Tunisian Society of Cardiology and Cardiovascular Surgery
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 5 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing cardiac implantable electronic device procedure
Key inclusion criteria (3 listed)
- Patients originated from Tunisia
- Signed informed consent
- Patients undergoing a cardiac implantable electronic device procedure
Key exclusion criteria (1 listed)
- Informed Consent not given
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac Implantable Electronic DevicesDescription of Cardiac Implantable Electronic Devices | Device | – |
Primary outcome
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
1 secondary outcome
Heart complication
Time frame: at 12 months of follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Derived from this study: PubMed 38588529Chabrak S, Haggui A, Allouche E, Ouali S, Ben Halima A, Kacem S, Krichen S, Marrakchi S, Fehri W, Mourali MS, Jabbari Z, Ben Halima M, Neffati E, Heraiech A, Slim M, Kachboura S, Gamra H, Hassine M, Kraiem S, Kammoun S, Bezdah L, Jridi G, Bouraoui H, Kammoun S, Hammami R, Chettaoui R, Ben Ameur Y, Azaiez F, Tlili R, Battikh K, Ben Slima H, Chrigui R, Fazaa S, Sanaa I, Ellouz Y, Mosrati M, Milouchi S, Jarmouni S, Ayadi W, Akrout M, Razgallah R, Neffati W, Drissa M, Charfeddine S, Abdessalem S, Abid L, Zakhama L. National Tunisian Study of Cardiac Implantable Electronic Devices: Design and Protocol for a Nationwide Multicenter Prospective Observational Study. JMIR Res Protoc. 2024 Apr 8;13:e47525. doi: 10.2196/47525.
- Tunisian Society of Cardiology and Cardiovascular Surgery WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonia Chabrak, MD study chair
Tunisian Society of Cardiology and Cardiovascular Surgery
Abdeddayem Haggui, MD study director
Tunisian Society of Cardiology and Cardiovascular Surgery
Salma Krichène, MD principal investigator
Tunisian Society of Cardiology and Cardiovascular Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Implantable Electronic Devices, run by Dacima Consulting at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of patients undergoing cardiac implantable electronic devices in Tunisia (time frame: at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05361759, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2023.