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

Condition(s) targeted: Ventricular Tachycardia; Ventricular Fibrillation

Intervention: Prizm, Vitality, Renewal (Device)

Phase: Phase 4

Status: Completed

Sponsored by: Guidant Corporation

Official(s) and/or principal investigator(s):
Antoine LEENHARD, MD, Principal Investigator, Affiliation: Hôpital Lariboisière, Paris

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.

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

Study design: Prospective

Primary outcome:

Time to first appropriate therapy

Time to first inappropriate therapy

Secondary outcome:

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).

Type of treatment ATP/shock

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

CHU Pontchaillou, Rennes 35033, France

CHU Michalon, Grenoble 38043, France

CHU Angers, Angers 49033, France

CHU Tours, Tours 37044, France

CHU Montpellier, Montpellier 34295, France

CHU Nantes, Nantes 34295, France

CHU Rangueil, Toulouse 31403, France

CHU Rouen, Rouen 76031, France

CHU Clermont Ferrand, Clermont Ferrand 63003, France

GH La Timone, Marseille 13385, France

CH St. Joseph, Marseille 13008, France

CH Amiens, Amiens 80054, France

CH Besancon, Besancon 25030, France

CHG Chateauroux, Chateauroux 36019, France

CHU Hopital la Cavale Blanche, Brest 29609, France

CH La Roche sur Yon, La Roche sur Yon 85025, France

CHU D'Orleans, Orleans 45000, France

CHU Dupuytren, Limoges 87042, France

Hopital Antoine Beclere, Clamart 92140, France

Hopital Angouleme, Angouleme 16470, France

Hopital Nord, Marseille 13915, France

Hopital Neuro-cardiologique, Lyon 69394, France

Hopital Cote de Nacre, Caen 14033, France

CHRU Robert Debré, Reims 51092, France

CH Avignon, Avignon 84902, France

CMC Arnaud Tzanck, St. Laurent du Var 6700, France

CHG Aix en Provence, Aix en Provence 13616, France

Hôpital Princesse de Grâce, Monaco 98000, France

CHG Albi, Albi 81000, France

CHG Pau, Pau 64046, France

CHU Nice, Nice 6002, France

CHG Martigues, Martigues 13696, France

CHU Toulon, Toulon 83056, France

Starting date: May 2002
Ending date: August 2007
Last updated: December 12, 2007