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OpenTrials
Completed

NCT Number: NCT01992458

Primary Prevention ICD French Registry

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique Pasteur

Toulouse, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 3-year

Secondary outcomes

  1. Cause-of-Death Analysis

    Time frame: 3-year

Sponsors and collaborators

Lead sponsor

Clinique Pasteur

Other

Collaborators

  • Central Hospital, Nancy, France
  • Centre Cardiologique du Nord, St Denis
  • Clinique Pasteur Toulouse
  • European Georges Pompidou Hospital
  • Hopital Antoine Beclere, Clamart
  • Nouvelles Cliniques Nantaises, Nantes
  • Rennes University Hospital
  • University Hospital, Bordeaux
  • University Hospital, Grenoble
  • University Hospital, Lille
  • University Hospital, Marseille
  • University Hospital, Tours

Registry information

Official study title

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

Acronym: DAI-PP

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 25, 2013
Registry last updated
Nov 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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