National Tunisian Registry of Cardiac Implantable Electronic Devices

NCT05361759 | Completed

• 1 other identifier: DAC-012-NATURECIED
• Study Type: observational
• Target: 1,518
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Cardiac Implantable Electronic Devices; Heart; Pacemaker; Implantable Cardioverter Defibrillator; Cardiac Loop Recorders; Biventricular Pacemakers; Heart rhythm disorder

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Heart complication

  at 12 months of follow-up

Interventions

Cardiac Implantable Electronic Devices DEVICE

Description of Cardiac Implantable Electronic Devices

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing cardiac implantable electronic device procedure

You may qualify if:

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

You may not qualify if:

• Informed Consent not given

Sponsors & Collaborators

• Dacima Consulting: lead
• Tunisian Society of Cardiology and Cardiovascular Surgery: collaborator

Study Sites (1)

The Tunisian Society of Cardiology and CardioVascular Surgery

Tunis, 1053, Tunisia

Location

Related Publications (1)

• 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.

  PMID: 38588529 DERIVED

Related Links

• Tunisian Society of Cardiology and Cardiovascular Surgery Website

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2022
• First Posted: May 5, 2022
• Study Start: January 18, 2021
• Primary Completion: August 15, 2023
• Study Completion: August 15, 2023
• Last Updated: August 15, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)