OPERA: French Observational Study on Patients Implanted With a Guidant PRIZM or Vitality Defibrillator
Sponsor
Boston Scientific Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT00180375
Collaborator
(none)
636
33
63
19.3
0.3
Study Details
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 | Phase |
|---|---|---|
|
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 1, 2002
Actual Primary Completion Date
:
Aug 1, 2007
Actual Study Completion Date
:
Aug 1, 2007
Outcome Measures
Primary Outcome Measures
- Time to first appropriate therapy [2 year-follow-up]
- Time to first inappropriate therapy [2 year-follow-up]
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). [2 year-follow-up]
- Type of treatment ATP/shock [2 year-follow-up]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHG Aix en Provence | Aix en Provence | France | 13616 | |
| 2 | CHG Albi | Albi | France | 81000 | |
| 3 | CH Amiens | Amiens | France | 80054 | |
| 4 | CHU Angers | Angers | France | 49033 | |
| 5 | Hopital Angouleme | Angouleme | France | 16470 | |
| 6 | CH Avignon | Avignon | France | 84902 | |
| 7 | CH Besancon | Besancon | France | 25030 | |
| 8 | CHU Hopital la Cavale Blanche | Brest | France | 29609 | |
| 9 | Hopital Cote de Nacre | Caen | France | 14033 | |
| 10 | CHG Chateauroux | Chateauroux | France | 36019 | |
| 11 | Hopital Antoine Beclere | Clamart | France | 92140 | |
| 12 | CHU Clermont Ferrand | Clermont Ferrand | France | 63003 | |
| 13 | CHU Michalon | Grenoble | France | 38043 | |
| 14 | CH La Roche sur Yon | La Roche sur Yon | France | 85025 | |
| 15 | CHU Dupuytren | Limoges | France | 87042 | |
| 16 | Hopital Neuro-cardiologique | Lyon | France | 69394 | |
| 17 | CH St. Joseph | Marseille | France | 13008 | |
| 18 | GH La Timone | Marseille | France | 13385 | |
| 19 | Hopital Nord | Marseille | France | 13915 | |
| 20 | CHG Martigues | Martigues | France | 13696 | |
| 21 | Hôpital Princesse de Grâce | Monaco | France | 98000 | |
| 22 | CHU Montpellier | Montpellier | France | 34295 | |
| 23 | CHU Nantes | Nantes | France | 34295 | |
| 24 | CHU Nice | Nice | France | 6002 | |
| 25 | CHU D'Orleans | Orleans | France | 45000 | |
| 26 | CHG Pau | Pau | France | 64046 | |
| 27 | CHRU Robert Debré | Reims | France | 51092 | |
| 28 | CHU Pontchaillou | Rennes | France | 35033 | |
| 29 | CHU Rouen | Rouen | France | 76031 | |
| 30 | CMC Arnaud Tzanck | St. Laurent du Var | France | 6700 | |
| 31 | CHU Toulon | Toulon | France | 83056 | |
| 32 | CHU Rangueil | Toulouse | France | 31403 | |
| 33 | CHU Tours | Tours | France | 37044 |
Sponsors and Collaborators
- Boston Scientific Corporation
Investigators
- Principal Investigator: Antoine LEENHARD, MD, Hôpital Lariboisière, Paris
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00180375
Other Study ID Numbers:
- OPERA Registry
- 902194
First Posted:
Sep 16, 2005
Last Update Posted:
Feb 23, 2017
Last Verified:
Feb 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms: