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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00180375
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Ventricular Tachycardia Ventricular Fibrillation Device: Prizm, Vitality, Renewal

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 Design

Study Type : Observational
Actual Enrollment : 636 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: OPERA: French Observational Study on Patients Implanted With a Guidant PRIZM or Vitality Defibrillator
Study Start Date : May 2002
Primary Completion Date : August 2007
Study Completion Date : August 2007


Groups and Cohorts

Intervention Details:
    Device: Prizm, Vitality, Renewal
    Follow-up during 2 years
    Other Name: ICD and CRT-D

Outcome Measures

Primary Outcome Measures :
  1. Time to first appropriate therapy [ Time Frame: 2 year-follow-up ]
  2. Time to first inappropriate therapy [ Time Frame: 2 year-follow-up ]

Secondary Outcome Measures :
  1. 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). [ Time Frame: 2 year-follow-up ]
  2. Type of treatment ATP/shock [ Time Frame: 2 year-follow-up ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with a conventional indication of ICD or CRT-D
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00180375


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

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00180375     History of Changes
Other Study ID Numbers: OPERA Registry
902194
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Ventricular
Ventricular Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes