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

Boston Scientific

Status: Completed

Conditions: Ventricular Fibrillation; Ventricular Tachycardia

Treatments: Device: Prizm, Vitality, Renewal

Study type: Observational

Funder types: Industry

Identifiers

NCT00180375

OPERA Registry

902194

Details and patient eligibility

About

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.

Full 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.

Enrollment: 636 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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