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National Tunisian Registry of Cardiac Implantable Electronic Devices

NCT05361759 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1518

Last updated 2023-08-15

No results posted yet for this study

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

Interventions

DEVICE

Cardiac Implantable Electronic Devices

Description of Cardiac Implantable Electronic Devices

Sponsors & Collaborators

  • Tunisian Society of Cardiology and Cardiovascular Surgery

    collaborator OTHER

  • Dacima Consulting

    lead OTHER

Principal Investigators

  • Sonia Chabrak, MD · Tunisian Society of Cardiology and Cardiovascular Surgery

  • Abdeddayem Haggui, MD · Tunisian Society of Cardiology and Cardiovascular Surgery

  • Salma Krichène, MD · Tunisian Society of Cardiology and Cardiovascular Surgery

  • Slim Kacem, MD · Tunisian Society of Cardiology and Cardiovascular Surgery

  • Sonia Marrakchi, MD · Tunisian Society of Cardiology and Cardiovascular Surgery

  • Emna Allouche, MD · Tunisian Society of Cardiology and Cardiovascular Surgery

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-18
Primary Completion
2023-08-15
Completion
2023-08-15

Countries

  • Tunisia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05361759 on ClinicalTrials.gov