ClinicalTrials.gg
CompletedNCT00180375Updated Feb 23, 2017

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

An observational study in Ventricular Tachycardia and Ventricular Fibrillation, sponsored by Boston Scientific Corporation. Completed at 33 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-23.

Sponsored by Boston Scientific Corporation · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
636
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Ventricular Tachycardia
  • Ventricular Fibrillation
03

In context

Tachycardia, Ventricular

443 studies on the registry are indexed under Tachycardia, Ventricular; 120 are open to participants now.

This study's enrollment of 636 is above the median of 200 across 148 observational studies indexed under Tachycardia, Ventricular.

Browse Tachycardia, Ventricular studies →

Lead sponsor

Boston Scientific Corporation is the lead sponsor of 527 studies on the registry; 40 are open to participants now.

Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Indication for an ICD according to current guidelines, incl. prophylactic indication

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
636 participants (actual)

Interventions

  • DevicePrizm, Vitality, Renewal

    Follow-up during 2 years

    Also known as: ICD and CRT-D

06

What researchers measure

Primary outcomes

  1. Time to first appropriate therapy

    Time frame: 2 year-follow-up

  2. Time to first inappropriate therapy

    Time frame: 2 year-follow-up

Secondary outcomes

  1. 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. Type of treatment ATP/shock

    Time frame: 2 year-follow-up

07

Study locations

33 sites
  • CHG Aix en Provence
    Aix-en-Provence, 13616, France
  • CHG Albi
    Albi, 81000, France
  • CH Amiens
    Amiens, 80054, France
  • CHU Angers
    Angers, 49033, France
  • Hopital Angouleme
    Angoulême, 16470, France
  • CH Avignon
    Avignon, 84902, France
  • CH Besancon
    Besançon, 25030, France
  • CHU Hopital la Cavale Blanche
    Brest, 29609, France
  • Hopital Cote de Nacre
    Caen, 14033, France
  • CHG Chateauroux
    Châteauroux, 36019, France
  • Hopital Antoine Beclere
    Clamart, 92140, France
  • CHU Clermont Ferrand
    Clermont-Ferrand, 63003, France
  • CHU Michalon
    Grenoble, 38043, France
  • CH La Roche sur Yon
    La Roche-sur-Yon, 85025, France
  • CHU Dupuytren
    Limoges, 87042, France
  • Hopital Neuro-cardiologique
    Lyon, 69394, France
  • CH St. Joseph
    Marseille, 13008, France
  • GH La Timone
    Marseille, 13385, France
  • Hopital Nord
    Marseille, 13915, France
  • CHG Martigues
    Martigues, 13696, France
  • Hôpital Princesse de Grâce
    Monaco, 98000, France
  • CHU Montpellier
    Montpellier, 34295, France
  • CHU Nantes
    Nantes, 34295, France
  • CHU Nice
    Nice, 6002, France
  • CHU D'Orleans
    Orléans, 45000, France
  • CHG Pau
    Pau, 64046, France
  • CHRU Robert Debré
    Reims, 51092, France
  • CHU Pontchaillou
    Rennes, 35033, France
  • CHU Rouen
    Rouen, 76031, France
  • CMC Arnaud Tzanck
    Saint-Laurent-du-Var, 6700, France
  • CHU Toulon
    Toulon, 83056, France
  • CHU Rangueil
    Toulouse, 31403, France
  • CHU Tours
    Tours, 37044, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2002, a primary completion of Aug 2007 and a completion of Aug 2007. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 12, 2005
First posted
Sep 16, 2005
Start
May 2002
Primary completionActual
Aug 2007
CompletionActual
Aug 2007
Last update
Feb 23, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00180375
Responsible party
Sponsor
First posted
Sep 16, 2005
Start date
May 2002
Primary completion
Aug 2007
Completion
Aug 2007
Last update
Feb 23, 2017

Study contacts

Antoine LEENHARD, MD
principal investigator · Hôpital Lariboisière, Paris

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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