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

February 17, 2017 updated by: Boston Scientific Corporation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Device: Prizm, Vitality, Renewal

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.

Study Type

Observational

Enrollment (Actual)

636

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Aix en Provence, France, 13616
    - CHG Aix en Provence
  - Albi, France, 81000
    - CHG Albi
  - Amiens, France, 80054
    - CH Amiens
  - Angers, France, 49033
    - CHU Angers
  - Angouleme, France, 16470
    - Hopital Angouleme
  - Avignon, France, 84902
    - CH Avignon
  - Besancon, France, 25030
    - CH Besancon
  - Brest, France, 29609
    - CHU Hopital la Cavale Blanche
  - Caen, France, 14033
    - Hôpital Côte de Nacre
  - Chateauroux, France, 36019
    - CHG Chateauroux
  - Clamart, France, 92140
    - Hopital Antoine Beclere
  - Clermont Ferrand, France, 63003
    - CHU Clermont Ferrand
  - Grenoble, France, 38043
    - CHU Michalon
  - La Roche sur Yon, France, 85025
    - Ch La Roche Sur Yon
  - Limoges, France, 87042
    - CHU Dupuytren
  - Lyon, France, 69394
    - Hopital Neuro-cardiologique
  - Marseille, France, 13915
    - Hopital Nord
  - Marseille, France, 13008
    - CH St. Joseph
  - Marseille, France, 13385
    - GH La Timone
  - Martigues, France, 13696
    - Chg Martigues
  - Monaco, France, 98000
    - Hôpital Princesse de Grâce
  - Montpellier, France, 34295
    - CHU Montpellier
  - Nantes, France, 34295
    - Chu Nantes
  - Nice, France, 6002
    - CHU Nice
  - Orleans, France, 45000
    - CHU d'Orléans
  - Pau, France, 64046
    - CHG Pau
  - Reims, France, 51092
    - CHRU Robert Debré
  - Rennes, France, 35033
    - CHU Pontchaillou
  - Rouen, France, 76031
    - CHU Rouen
  - St. Laurent du Var, France, 6700
    - CMC Arnaud Tzanck
  - Toulon, France, 83056
    - Chu Toulon
  - Toulouse, France, 31403
    - CHU Rangueil
  - Tours, France, 37044
    - CHU Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients with a conventional indication of ICD or CRT-D

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to first appropriate therapy Time Frame: 2 year-follow-up	2 year-follow-up
Time to first inappropriate therapy Time Frame: 2 year-follow-up	2 year-follow-up

Secondary Outcome Measures

Outcome 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). Time Frame: 2 year-follow-up	2 year-follow-up
Type of treatment ATP/shock Time Frame: 2 year-follow-up	2 year-follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

Principal Investigator: Antoine LEENHARD, MD, Hôpital Lariboisière, Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2002

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria