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| Sponsored by: |
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: | Prospective |
| Official Title: | OPERA: French Observational Study on Patients Implanted With a Guidant PRIZM or Vitality Defibrillator |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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 | |
| Principal Investigator: | Antoine LEENHARD, MD | Hôpital Lariboisière, Paris |
More Information
| Responsible Party: | Guidant France ( Elisabeth Mouton ) |
| Study ID Numbers: | OPERA Registry, 902194 |
| Study First Received: | September 12, 2005 |
| Last Updated: | December 12, 2007 |
| ClinicalTrials.gov Identifier: | NCT00180375 |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
Heart Diseases Tachycardia Paroxysmal ventricular fibrillation |
Tachycardia, Ventricular Ventricular Fibrillation Arrhythmias, Cardiac |
|
Pathologic Processes Cardiovascular Diseases |
