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Ventricular TachycardiaNCT00180375

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

An observational study of Ventricular Tachycardia and Ventricular Fibrillation, run by Boston Scientific Corporation at 33 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Prizm, Vitality, Renewal
Type of treatment
Medical device
How many people
636 participants
Where
33 sitesFrance
Study dates
May 2002to Aug 2007
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

33 sites in 1 country.

33 sites in 1 country

France33 sites

  • CHG Aix en Provence

    Aix-en-Provence, 13616

  • CHG Albi

    Albi, 81000

  • CH Amiens

    Amiens, 80054

  • CHU Angers

    Angers, 49033

  • Hopital Angouleme

    Angoulême, 16470

  • CH Avignon

    Avignon, 84902

  • CH Besancon

    Besançon, 25030

  • CHU Hopital la Cavale Blanche

    Brest, 29609

  • Hopital Cote de Nacre

    Caen, 14033

  • CHG Chateauroux

    Châteauroux, 36019

  • Hopital Antoine Beclere

    Clamart, 92140

  • CHU Clermont Ferrand

    Clermont-Ferrand, 63003

  • CHU Michalon

    Grenoble, 38043

  • CH La Roche sur Yon

    La Roche-sur-Yon, 85025

  • CHU Dupuytren

    Limoges, 87042

  • Hopital Neuro-cardiologique

    Lyon, 69394

  • CH St. Joseph

    Marseille, 13008

  • GH La Timone

    Marseille, 13385

  • Hopital Nord

    Marseille, 13915

  • CHG Martigues

    Martigues, 13696

  • Hôpital Princesse de Grâce

    Monaco, 98000

  • CHU Montpellier

    Montpellier, 34295

  • CHU Nantes

    Nantes, 34295

  • CHU Nice

    Nice, 6002

  • CHU D'Orleans

    Orléans, 45000

  • CHG Pau

    Pau, 64046

  • CHRU Robert Debré

    Reims, 51092

  • CHU Pontchaillou

    Rennes, 35033

  • CHU Rouen

    Rouen, 76031

  • CMC Arnaud Tzanck

    Saint-Laurent-du-Var, 6700

  • CHU Toulon

    Toulon, 83056

  • CHU Rangueil

    Toulouse, 31403

  • CHU Tours

    Tours, 37044

Other trials in France

About this study

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.

Being tested
Prizm, Vitality, Renewal
Medical subject headings
Tachycardia, Ventricular, Ventricular Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prizm, Vitality, RenewalDevice

    Also called ICD and CRT-D

    Follow-up during 2 years

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to first appropriate therapy

    Measured: 2 year-follow-up

  2. Time to first inappropriate therapy

    Measured: 2 year-follow-up

Secondary outcomes (2)

  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).

    Measured: 2 year-follow-up

  2. Type of treatment ATP/shock

    Measured: 2 year-follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2005 (estimated)
  2. Study startMay 2002
  3. Primary completionAug 2007
  4. Study completionAug 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
636 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00180375
Sponsor's protocol ID
OPERA Registry
Other IDs
902194
Status last verified
Feb 2017
First submitted
12 Sep 2005
Last updated
23 Feb 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Ventricular Tachycardia and Ventricular Fibrillation, run by Boston Scientific Corporation at 33 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to first appropriate therapy (time frame: 2 year-follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00180375.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.

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