NCT00180375

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
636

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2002

Longer than P75 for all trials

Geographic Reach
1 country

33 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

5.3 years

First QC Date

September 12, 2005

Last Update Submit

February 17, 2017

Conditions

Ventricular TachycardiaVentricular Fibrillation

Outcome Measures

Primary Outcomes (2)

  • Time to first appropriate therapy

    2 year-follow-up

  • Time to first inappropriate therapy

    2 year-follow-up

Secondary Outcomes (2)

  • 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).

    2 year-follow-up

  • Type of treatment ATP/shock

    2 year-follow-up

Interventions

Prizm, Vitality, RenewalDEVICE

Follow-up during 2 years

Also known as: ICD and CRT-D

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (33)

CHG Aix en Provence

Aix-en-Provence, 13616, France

Location

CHG Albi

Albi, 81000, France

Location

CH Amiens

Amiens, 80054, France

Location

CHU Angers

Angers, 49033, France

Location

Hopital Angouleme

Angoulême, 16470, France

Location

CH Avignon

Avignon, 84902, France

Location

CH Besancon

Besançon, 25030, France

Location

CHU Hopital la Cavale Blanche

Brest, 29609, France

Location

Hopital Cote de Nacre

Caen, 14033, France

Location

CHG Chateauroux

Châteauroux, 36019, France

Location

Hopital Antoine Beclere

Clamart, 92140, France

Location

CHU Clermont Ferrand

Clermont-Ferrand, 63003, France

Location

CHU Michalon

Grenoble, 38043, France

Location

CH La Roche sur Yon

La Roche-sur-Yon, 85025, France

Location

CHU Dupuytren

Limoges, 87042, France

Location

Hopital Neuro-cardiologique

Lyon, 69394, France

Location

CH St. Joseph

Marseille, 13008, France

Location

GH La Timone

Marseille, 13385, France

Location

Hopital Nord

Marseille, 13915, France

Location

CHG Martigues

Martigues, 13696, France

Location

Hôpital Princesse de Grâce

Monaco, 98000, France

Location

CHU Montpellier

Montpellier, 34295, France

Location

CHU Nantes

Nantes, 34295, France

Location

CHU Nice

Nice, 6002, France

Location

CHU D'Orleans

Orléans, 45000, France

Location

CHG Pau

Pau, 64046, France

Location

CHRU Robert Debré

Reims, 51092, France

Location

CHU Pontchaillou

Rennes, 35033, France

Location

CHU Rouen

Rouen, 76031, France

Location

CMC Arnaud Tzanck

Saint-Laurent-du-Var, 6700, France

Location

CHU Toulon

Toulon, 83056, France

Location

CHU Rangueil

Toulouse, 31403, France

Location

CHU Tours

Tours, 37044, France

Location

MeSH Terms

Conditions

Tachycardia, VentricularVentricular Fibrillation

Interventions

Defibrillators, Implantable

Condition Hierarchy (Ancestors)

TachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DefibrillatorsElectrodesElectrical Equipment and SuppliesEquipment and SuppliesElectrodes, ImplantedProstheses and Implants

Study Officials

  • Antoine LEENHARD, MD

    Hôpital Lariboisière, Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

May 1, 2002

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

February 23, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(33)