Clinical trial NCT00180375: OPERA: French Observational Study on Patients Implanted With a Guidant PRIZM or Vitality Defibrillator
Official title: OPERA: French Observational Study on Patients Implanted With a Guidant PRIZM or Vitality Defibrillator
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventricular Tachycardia
Ventricular Fibrillation
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 636
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with a conventional indication of ICD or CRT-D

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.

Eligibility 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

Primary outcomes:
measure: Time to first appropriate therapy
timeFrame: 2 year-follow-up
measure: Time to first inappropriate therapy
timeFrame: 2 year-follow-up
Secondary outcomes:
measure: 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).
timeFrame: 2 year-follow-up
measure: Type of treatment ATP/shock
timeFrame: 2 year-follow-up
Other outcomes:
Locations:
city: Aix en Provence
country: France
facility: CHG Aix en Provence
city: Albi
country: France
facility: CHG Albi
city: Amiens
country: France
facility: CH Amiens
city: Angers
country: France
facility: CHU Angers
city: Angouleme
country: France
facility: Hopital Angouleme
city: Avignon
country: France
facility: CH Avignon
city: Besancon
country: France
facility: CH Besancon
city: Brest
country: France
facility: CHU Hopital la Cavale Blanche
city: Caen
country: France
facility: Hopital Cote de Nacre
city: Chateauroux
country: France
facility: CHG Chateauroux
city: Clamart
country: France
facility: Hopital Antoine Beclere
city: Clermont Ferrand
country: France
facility: CHU Clermont Ferrand
city: Grenoble
country: France
facility: CHU Michalon
city: La Roche sur Yon
country: France
facility: CH La Roche sur Yon
city: Limoges
country: France
facility: CHU Dupuytren
city: Lyon
country: France
facility: Hopital Neuro-cardiologique
city: Marseille
country: France
facility: CH St. Joseph
city: Marseille
country: France
facility: GH La Timone
city: Marseille
country: France
facility: Hopital Nord
city: Martigues
country: France
facility: CHG Martigues
city: Monaco
country: France
facility: Hôpital Princesse de Grâce
city: Montpellier
country: France
facility: CHU Montpellier
city: Nantes
country: France
facility: CHU Nantes
city: Nice
country: France
facility: CHU Nice
city: Orleans
country: France
facility: CHU D'Orleans
city: Pau
country: France
facility: CHG Pau
city: Reims
country: France
facility: CHRU Robert Debré
city: Rennes
country: France
facility: CHU Pontchaillou
city: Rouen
country: France
facility: CHU Rouen
city: St. Laurent du Var
country: France
facility: CMC Arnaud Tzanck
city: Toulon
country: France
facility: CHU Toulon
city: Toulouse
country: France
facility: CHU Rangueil
city: Tours
country: France
facility: CHU Tours
Study officials:
affiliation: Hôpital Lariboisière, Paris
name: Antoine LEENHARD, MD
role: PRINCIPAL_INVESTIGATOR
References: