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

This study has been completed.
Sponsor:
Information provided by:
Guidant Corporation
ClinicalTrials.gov Identifier:
NCT00180375
First received: September 12, 2005
Last updated: June 3, 2011
Last verified: June 2011
  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 4

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

Resource links provided by NLM:


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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Hopital Nord
Marseille, France, 13915
CH St. Joseph
Marseille, France, 13008
GH La Timone
Marseille, France, 13385
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
Guidant Corporation
Investigators
Principal Investigator: Antoine LEENHARD, MD Hôpital Lariboisière, Paris
  More Information

No publications provided

Responsible Party: Elisabeth Mouton, Guidant France
ClinicalTrials.gov Identifier: NCT00180375     History of Changes
Other Study ID Numbers: OPERA Registry, 902194
Study First Received: September 12, 2005
Last Updated: June 3, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on September 18, 2014