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| Name | Class |
|---|---|
| Tunisian Society of Cardiology and Cardiovascular Surgery | OTHER |
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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Implantable Electronic Devices | Device | Description of Cardiac Implantable Electronic Devices |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at 12 months of follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing cardiac implantable electronic device procedure
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| Name | Affiliation | Role |
|---|---|---|
| Sonia Chabrak, MD | Tunisian Society of Cardiology and Cardiovascular Surgery | Study Chair |
| Abdeddayem Haggui, MD | Tunisian Society of Cardiology and Cardiovascular Surgery | Study Director |
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Tunisian Society of Cardiology and CardioVascular Surgery | Tunis | 1053 | Tunisia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38588529 | Derived | 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. |
| Label | URL |
|---|---|
| Tunisian Society of Cardiology and Cardiovascular Surgery Website | View source |
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