Trials / Completed
CompletedNCT00180375
OPERA: French Observational Study on Patients Implanted With a Guidant PRIZM or Vitality Defibrillator
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 636 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Prizm, Vitality, Renewal | Follow-up during 2 years |
Timeline
- Start date
- 2002-05-01
- Primary completion
- 2007-08-01
- Completion
- 2007-08-01
- First posted
- 2005-09-16
- Last updated
- 2017-02-23
Locations
33 sites across 1 country: France
Source: ClinicalTrials.gov record NCT00180375. Inclusion in this directory is not an endorsement.