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National Tunisian Registry of Cardiac Implantable Electronic Devices (NATURE-CIED)

D

DACIMA

Status

Completed

Conditions

Cardiac Implantable Electronic Devices

Treatments

Device: Cardiac Implantable Electronic Devices

Study type

Observational

Funder types

Other

Identifiers

NCT05361759
DAC-012-NATURECIED

Details and patient eligibility

About

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.

Enrollment

1,518 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Informed Consent not given

Trial contacts and locations

1

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Central trial contact

Rabie Razgallah, MD; Sonia Chabrak, MD

Data sourced from clinicaltrials.gov

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