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

Boston Scientific Corporation636 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

636

Conditions

Ventricular Tachycardia Ventricular Fibrillation

Interventions

Prizm, Vitality, RenewalDEVICE

Follow-up during 2 years

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (33)

CHG Aix en Provence

Aix-en-Provence, France

Outcomes

Primary Outcomes

Time to first appropriate therapy

Time frame: 2 year-follow-up

Time to first inappropriate therapy

Time frame: 2 year-follow-up

Secondary Outcomes

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).

Time frame: 2 year-follow-up

Type of treatment ATP/shock

Time frame: 2 year-follow-up

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.