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Clinical Trials/NCT01992458
NCT01992458
Completed
N/A

Observatoire Multicentrique Français Des Porteurs de Défibrillateur Automatique Implantable en Prévention Primaire (Cardiopathie Ischémique ou Cardiomyopathie Dilatée)

Clinique Pasteur1 site in 1 country5,576 target enrollmentJanuary 2012
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ConditionsEvaluation of Primary Prevention ICD in Real Life

Overview

Phase
N/A
Intervention
Not specified
Conditions
Evaluation of Primary Prevention ICD in Real Life
Sponsor
Clinique Pasteur
Enrollment
5576
Locations
1
Primary Endpoint
Incidences of Appropriate Therapies (ATP and Shocks) and ICD-Related Complications
Status
Completed
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
November 2013
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Serge Boveda

MD

Clinique Pasteur

Eligibility Criteria

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

Outcomes

Primary Outcomes

Incidences of Appropriate Therapies (ATP and Shocks) and ICD-Related Complications

Time Frame: 3-year

Secondary Outcomes

  • Cause-of-Death Analysis(3-year)

Study Sites (1)

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