Ventricular Fibrillation, Ventricular Tachycardia
Conditions
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.
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.
Interventions
DEVICEPrizm, Vitality, Renewal
Follow-up during 2 years
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first appropriate therapy | 2 year-follow-up |
| Time to first inappropriate therapy | 2 year-follow-up |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
France
Outcome results
None listed