National Tunisian Registry of Cardiac Implantable Electronic Devices

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1518 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-18

Study Completion Date

2023-08-15

Brief Summary

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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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Detailed Description

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Conditions

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Cardiac Implantable Electronic Devices

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Cardiac Implantable Electronic Devices

Description of Cardiac Implantable Electronic Devices

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Informed Consent not given

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR