Primary Prevention ICD French Registry

Completed

• Conditions: Evaluation of Primary Prevention ICD in Real Life

• Registration Number: NCT01992458
• Lead Sponsor: Clinique Pasteur

Brief Summary

The indication of implantable cardioverter defibrillator (ICD) therapy for primary prevention of sudden cardiac death has been introduced later in France than in other parts of the World. Overall, we aimed to assess the risk-benefit ratio of this strategy over a 10 year period.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Status Verified: 2013-11
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Study First Submitted: 2013-11-12
• Study First Submitted QC: 2013-11-19
• Last Update Submitted: 2013-11-19
• Study First Posted: 2013-11-25
• Last Update Posted: 2013-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5576

Inclusion Criteria

• Coronary artery disease or dilated cardiomyopathy with low ejection fraction implanted with an ICD in the setting of primary prevention (criteria at the discretion of the physician)

Exclusion Criteria

• Setting of secondary prevention
• Other cardiopathies such as congenital, channelopathies, valvulopathies

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidences of Appropriate Therapies (ATP and Shocks) and ICD-Related Complications	3-year

Secondary Outcome Measures

Name	Time	Method
Cause-of-Death Analysis	3-year

Trial Locations

Locations (1)

Clinique Pasteur; 🇫🇷 Toulouse, France