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OPERA: French Observational Study on Patients Implanted With a Guidant PRIZM or Vitality Defibrillator

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ClinicalTrials.gov Identifier: NCT00180375
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

September 12, 2005
September 16, 2005
February 23, 2017
May 2002
August 2007   (Final data collection date for primary outcome measure)
  • Time to first appropriate therapy [ Time Frame: 2 year-follow-up ]
  • Time to first inappropriate therapy [ Time Frame: 2 year-follow-up ]
Not Provided
Complete list of historical versions of study NCT00180375 on ClinicalTrials.gov Archive Site
  • Influence of cardiopathy, EF, NYHA Class, Type of ventricular arrhythmia (MVT, PVT, VF), History of atrial and ventricular arrhythmias, medical treatment (betablockers and/or Amiodarone). [ Time Frame: 2 year-follow-up ]
  • Type of treatment ATP/shock [ Time Frame: 2 year-follow-up ]
Not Provided
Not Provided
Not Provided
 
OPERA: French Observational Study on Patients Implanted With a Guidant PRIZM or Vitality Defibrillator
OPERA: French Observational Study on Patients Implanted With a Guidant PRIZM or Vitality Defibrillator
This study evaluates the date of the first appropriate and/or inappropriate therapy in patients implanted with a Guidant PRIZM or VITALITY defibrillator and is evaluating eventual predictive risk factors for appropriate/inappropriate therapies as well as the influence of the programmed parameters on these therapies.
The registry measured the times to, and studied the determinants of, first appropriate (FAT) and inappropriate (FIT) therapy delivered by single, dual and triple chamber (CRT-D) ICD implanted for primary and secondary prevention indications.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
All patients with a conventional indication of ICD or CRT-D
  • Ventricular Tachycardia
  • Ventricular Fibrillation
Device: Prizm, Vitality, Renewal
Follow-up during 2 years
Other Name: ICD and CRT-D
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
636
700
August 2007
August 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Indication for an ICD according to current guidelines, incl. prophylactic indication

Exclusion Criteria:

  • pregnant or at birth bearing age without contraception, participation in another clinical trial, short life expectancy, geographically unstable for a follow-up at the investigational center
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00180375
OPERA Registry
902194
No
Not Provided
Plan to Share IPD: No
Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
Principal Investigator: Antoine LEENHARD, MD Hôpital Lariboisière, Paris
Boston Scientific Corporation
February 2017