OPERA: French Observational Study on Patients Implanted With a Guidant PRIZM or Vitality Defibrillator
- Conditions
- Ventricular TachycardiaVentricular 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
- Indication for an ICD according to current guidelines, incl. prophylactic indication
- 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
Name Time Method Time to first inappropriate therapy 2 year-follow-up Time to first appropriate therapy 2 year-follow-up
- Secondary Outcome Measures
Name Time Method 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/shock 2 year-follow-up
Related Research Topics
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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