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

Completed
Conditions
Ventricular Tachycardia
Ventricular Fibrillation
Registration Number
NCT00180375
Lead Sponsor
Boston Scientific Corporation
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 factors for appropriate/inappropriate therapies as well as the influence of the programmed parameters on these therapies.

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 primary and secondary prevention indications.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
636
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Time to first inappropriate therapy2 year-follow-up
Time to first appropriate therapy2 year-follow-up
Secondary Outcome Measures
NameTimeMethod
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).2 year-follow-up
Type of treatment ATP/shock2 year-follow-up

Trial Locations

Locations (33)

CHG Aix en Provence

🇫🇷

Aix en Provence, France

CHG Albi

🇫🇷

Albi, France

CH Amiens

🇫🇷

Amiens, France

CHU Angers

🇫🇷

Angers, France

Hopital Angouleme

🇫🇷

Angouleme, France

CH Avignon

🇫🇷

Avignon, France

CH Besancon

🇫🇷

Besancon, France

CHU Hopital la Cavale Blanche

🇫🇷

Brest, France

Hopital Cote de Nacre

🇫🇷

Caen, France

CHG Chateauroux

🇫🇷

Chateauroux, France

Scroll for more (23 remaining)
CHG Aix en Provence
🇫🇷Aix en Provence, France
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