Status:
COMPLETED
OPERA: French Observational Study on Patients Implanted With a Guidant PRIZM or Vitality Defibrillator
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Ventricular Tachycardia
Ventricular Fibrillation
Eligibility:
All Genders
18+ years
Brief Summary
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 fact...
Detailed Description
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 prim...
Eligibility Criteria
Inclusion
- Indication for an ICD according to current guidelines, incl. prophylactic indication
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2002
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
636 Patients enrolled
Trial Details
Trial ID
NCT00180375
Start Date
May 1 2002
End Date
August 1 2007
Last Update
February 23 2017
Active Locations (33)
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1
CHG Aix en Provence
Aix-en-Provence, France, 13616
2
CHG Albi
Albi, France, 81000
3
CH Amiens
Amiens, France, 80054
4
CHU Angers
Angers, France, 49033