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

This study has been completed.

First Received: September 12, 2005 Last Updated: April 22, 2009 History of Changes

Sponsor:	Guidant Corporation
Information provided by:	Guidant Corporation
ClinicalTrials.gov Identifier:	NCT00180375

Purpose

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.

Condition	Intervention	Phase
Ventricular Tachycardia Ventricular Fibrillation	Device: Prizm, Vitality, Renewal	Phase IV

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	OPERA: French Observational Study on Patients Implanted With a Guidant PRIZM or Vitality Defibrillator

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome catecholaminergic polymorphic ventricular tachycardia short QT syndrome

U.S. FDA Resources

Further study details as provided by Guidant Corporation:

Primary Outcome Measures:

Time to first appropriate therapy
Time to first inappropriate therapy

Secondary Outcome Measures:

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

Estimated Enrollment:	700
Study Start Date:	May 2002
Study Completion Date:	August 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00180375

Locations

France
CHU Pontchaillou
Rennes, France, 35033
CHU Michalon
Grenoble, France, 38043
CHU Angers
Angers, France, 49033
CHU Tours
Tours, France, 37044
CHU Montpellier
Montpellier, France, 34295
CHU Nantes
Nantes, France, 34295
CHU Rangueil
Toulouse, France, 31403
CHU Rouen
Rouen, France, 76031
CHU Clermont Ferrand
Clermont Ferrand, France, 63003
GH La Timone
Marseille, France, 13385
CH St. Joseph
Marseille, France, 13008
CH Amiens
Amiens, France, 80054
CH Besancon
Besancon, France, 25030
CHG Chateauroux
Chateauroux, France, 36019
CHU Hopital la Cavale Blanche
Brest, France, 29609
CH La Roche sur Yon
La Roche sur Yon, France, 85025
CHU Toulon
Toulon, France, 83056
CHU Dupuytren
Limoges, France, 87042
Hopital Antoine Beclere
Clamart, France, 92140
Hopital Angouleme
Angouleme, France, 16470
Hopital Nord
Marseille, France, 13915
Hopital Neuro-cardiologique
Lyon, France, 69394
Hopital Cote de Nacre
Caen, France, 14033
CHRU Robert Debré
Reims, France, 51092
CH Avignon
Avignon, France, 84902
CMC Arnaud Tzanck
St. Laurent du Var, France, 6700
CHG Aix en Provence
Aix en Provence, France, 13616
Hôpital Princesse de Grâce
Monaco, France, 98000
CHG Albi
Albi, France, 81000
CHG Pau
Pau, France, 64046
CHU Nice
Nice, France, 6002
CHG Martigues
Martigues, France, 13696
CHU D'Orleans
Orleans, France, 45000

Sponsors and Collaborators

Guidant Corporation

Investigators

Principal Investigator:

Antoine LEENHARD, MD

Hôpital Lariboisière, Paris

More Information

No publications provided

Responsible Party:	Guidant France ( Elisabeth Mouton )
Study ID Numbers:	OPERA Registry, 902194
Study First Received:	September 12, 2005
Last Updated:	April 22, 2009
ClinicalTrials.gov Identifier:	NCT00180375 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Tachycardia
Cardiovascular Diseases

Tachycardia, Ventricular
Ventricular Fibrillation
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on February 04, 2010