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NCT00180375 Clinical Trial

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

Ventricular Tachycardia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00180375
Other study ID # OPERA Registry
Secondary ID 902194
Status Completed
Phase N/A
First received September 12, 2005
Last updated February 17, 2017
Start date May 2002
Est. completion date August 2007

Study information
Verified date February 2017
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 636
Est. completion date August 2007
Est. primary completion date August 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Prizm, Vitality, Renewal
Follow-up during 2 years

Locations
Country Name City State
France 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 Hopital Antoine Beclere Clamart
France CHU Clermont Ferrand Clermont Ferrand
France CHU Michalon Grenoble
France CH La Roche sur Yon La Roche sur Yon
France CHU Dupuytren Limoges
France Hopital Neuro-cardiologique Lyon
France CH St. Joseph Marseille
France GH La Timone Marseille
France Hopital Nord Marseille
France CHG Martigues Martigues
France Hôpital Princesse de Grâce Monaco
France CHU Montpellier Montpellier
France CHU Nantes Nantes
France CHU Nice Nice
France CHU D'Orleans Orleans
France CHG Pau Pau
France CHRU Robert Debré Reims
France CHU Pontchaillou Rennes
France CHU Rouen Rouen
France CMC Arnaud Tzanck St. Laurent du Var
France CHU Toulon Toulon
France CHU Rangueil Toulouse
France CHU Tours Tours

Sponsors (1)
Lead Sponsor Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time to first appropriate therapy 2 year-follow-up
Primary Time to first inappropriate therapy 2 year-follow-up
Secondary 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
Secondary Type of treatment ATP/shock 2 year-follow-up
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