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

Official Title: “OPERA: French Observational Study on Patients Implanted With a Guidant PRIZM or Vitality Defibrillator”

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.

Intervention(s) in this Clinical Trial

• Device: Prizm, Vitality, Renewal

Primary Measures

• Time to first appropriate therapy
• Time to first inappropriate therapy

Secondary 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).
• Type of treatment ATP/shock

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Guidant Corporation Industry

Overall Clinical Trial Officials and Contacts

Antoine LEENHARD, MD Principal Investigator Hôpital Lariboisière, Paris  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00180375

Study ID Number: OPERA Registry

ClinicalTrials.gov Identifier: NCT00180375

Health Authority: France: Afssaps - French Health Products Safety Agency