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Primary Prevention ICD French Registry (DAI-PP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01992458
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : November 25, 2013
Sponsor:
Collaborators:
Clinique Pasteur Toulouse
European Georges Pompidou Hospital
University Hospital, Grenoble
University Hospital, Bordeaux
University Hospital, Lille
University Hospital, Marseille
Centre Cardiologique du Nord, St Denis
Nouvelles Cliniques Nantaises, Nantes
Hopital Antoine Beclere, Clamart
Rennes University Hospital
Central Hospital, Nancy, France
University Hospital, Tours
Information provided by (Responsible Party):
Serge Boveda, 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.

Condition or disease
Evaluation of Primary Prevention ICD in Real Life

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Study Type : Observational
Actual Enrollment : 5576 participants
Time Perspective: Retrospective
Official Title: Observatoire Multicentrique Français Des Porteurs de Défibrillateur Automatique Implantable en Prévention Primaire (Cardiopathie Ischémique ou Cardiomyopathie Dilatée)
Study Start Date : January 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013



Primary Outcome Measures :
  1. Incidences of Appropriate Therapies (ATP and Shocks) and ICD-Related Complications [ Time Frame: 3-year ]

Secondary Outcome Measures :
  1. Cause-of-Death Analysis [ Time Frame: 3-year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients from 12 medical centers implanted with an implantable cardioverter defibrillator (ICD) in the setting of primary prevention since Jan. 1, 1997, in France
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01992458


Locations
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France
Clinique Pasteur
Toulouse, France
Sponsors and Collaborators
Clinique Pasteur
Clinique Pasteur Toulouse
European Georges Pompidou Hospital
University Hospital, Grenoble
University Hospital, Bordeaux
University Hospital, Lille
University Hospital, Marseille
Centre Cardiologique du Nord, St Denis
Nouvelles Cliniques Nantaises, Nantes
Hopital Antoine Beclere, Clamart
Rennes University Hospital
Central Hospital, Nancy, France
University Hospital, Tours
Investigators
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Principal Investigator: Serge Boveda, MD Clinique Pasteur
Principal Investigator: Eloi Marijon, MD Hopital européen Georges Pompidou
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Serge Boveda, MD, Clinique Pasteur
ClinicalTrials.gov Identifier: NCT01992458    
Other Study ID Numbers: 913203
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013
Keywords provided by Serge Boveda, Clinique Pasteur:
implantable cardioverter defibrillator
death
shock
mortality
complication
sudden death