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.

Study Timeline

• Study Start: 2002-05
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-16
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-17
• Last Update Posted: 2017-02-23

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

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

Trial Locations

Locations (33)

CH Besancon; 🇫🇷 Besancon, France

CH Amiens; 🇫🇷 Amiens, France

Hopital Antoine Beclere; 🇫🇷 Clamart, France

CHU Angers; 🇫🇷 Angers, France

CHU Michalon; 🇫🇷 Grenoble, France

CH La Roche sur Yon; 🇫🇷 La Roche sur Yon, France

CH St. Joseph; 🇫🇷 Marseille, France

CHG Aix en Provence; 🇫🇷 Aix en Provence, France

CHG Martigues; 🇫🇷 Martigues, France

CHU Dupuytren; 🇫🇷 Limoges, France

CHU Toulon; 🇫🇷 Toulon, France

Hopital Neuro-cardiologique; 🇫🇷 Lyon, France

Hôpital Princesse de Grâce; 🇫🇷 Monaco, France

Hopital Angouleme; 🇫🇷 Angouleme, France

CHU Rouen; 🇫🇷 Rouen, France

CMC Arnaud Tzanck; 🇫🇷 St. Laurent du Var, France

CHU Tours; 🇫🇷 Tours, France

CHU Rangueil; 🇫🇷 Toulouse, France

CH Avignon; 🇫🇷 Avignon, France

CHG Chateauroux; 🇫🇷 Chateauroux, France

CHG Albi; 🇫🇷 Albi, France

CHU Hopital la Cavale Blanche; 🇫🇷 Brest, France

Hopital Cote de Nacre; 🇫🇷 Caen, France

CHU Clermont Ferrand; 🇫🇷 Clermont Ferrand, France

GH La Timone; 🇫🇷 Marseille, France

Hopital Nord; 🇫🇷 Marseille, France

CHU Montpellier; 🇫🇷 Montpellier, France

CHU D'Orleans; 🇫🇷 Orleans, France

CHRU Robert Debré; 🇫🇷 Reims, France

CHU Pontchaillou; 🇫🇷 Rennes, France

CHU Nantes; 🇫🇷 Nantes, France

CHU Nice; 🇫🇷 Nice, France

CHG Pau; 🇫🇷 Pau, France