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Leader - Evaluation of Endotak Reliance

NCT ID: NCT00180349

Last Updated: 2017-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

904 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-12-31

Study Completion Date

2009-07-31

Brief Summary

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The objective of this study is to demonstrate the efficacy of the ENDOTAK® RELIANCE™ defibrillation leads connected to a defibrillator or a cardiac resynchronization defibrillator from implant until 12 months.

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Detailed Description

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Baseline and clinical data were collected at inclusion, as were data on procedural characteristics, device implantation-related adverse events and device programming at the time of hospital discharge. Patients were subsequently divided in two groups: patients who underwent VF induction at implantation or before hospital discharge(VF induction group); and patients who did not undergo VF induction (untested group).The patients were followed up at 3-6 months and at12 months after the implantation. VF induction procedures were left to the investigator's discretion, but reasons for not performing a VF induction at implantation were recorded prospectively. ICD programming parameters for tachycardia or bradycardia were also left at the investigator's discretion.

Conditions

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Ventricular Tachycardia Ventricular Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Endotak Reliance

Endotak Reliance is a defibrillation lead delivering pacing and defibrillation therapy to the ventricle as needed.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* ICD indication according to current guidelines with or without cardiac resynchronization therapy, being implanted with a Guidant ENDOTAK RELIANCE defibrillation lead as first implant, age above 18 years, able to understand the nature of the study and to be available for all follow-ups, having given consent in writing for anonymous data collection, life expectancy \> 1 year.

Exclusion Criteria

* device replacement without concomitant implant of a Reliance defibrillation lead, pregnancy or of birth bearing age without contraception, participation in another clinical study, short life expectancy due to other medical conditions, not willing to sign the consent form, geographically unstable for a defibrillator follow-up as required per protocol, having a ventricular arrhythmia, that can be treated by drugs or surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicolas Sadoul, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Brabois, Nancy

Arnaud Lazarus, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique Bizet, Paris

Locations

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CH Amiens

Amiens, , France

Site Status

CHU Angers

Angers, , France

Site Status

Hôpital Angoulème

Angoulème, , France

Site Status

Clinique Cardiologique Aressy

Aressy, , France

Site Status

CH Avignon

Avignon, , France

Site Status

CHU du Morvan

Brest, , France

Site Status

Hôpital Côte de Nacre

Caen, , France

Site Status

CHU Henri Mondor

Créteil, , France

Site Status

CHU Michalon

Grenoble, , France

Site Status

CH Hôpital Nord

Marseille, , France

Site Status

CHU La Timone

Marseille, , France

Site Status

CHU Montpellier

Montpellier, , France

Site Status

CHU Brabois

Nancy, , France

Site Status

Nouvelle Clinique Nantaise

Nantes, , France

Site Status

CHU Nantes

Nantes, , France

Site Status

CHU Nice

Nice, , France

Site Status

CHU D'Orleans

Orléans, , France

Site Status

Clinique Bizet

Paris, , France

Site Status

CHG Pau

Pau, , France

Site Status

CHU Pontchaillou

Rennes, , France

Site Status

CHU Rouen

Rouen, , France

Site Status

Centre cardiologique du Nord

Saint-Denis, , France

Site Status

CMC Arnaud Tzanck

Saint-Laurent-du-Var, , France

Site Status

CHU Rangueil

Toulouse, , France

Site Status

Clinique St. Gatien

Tours, , France

Site Status

Countries

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France

Other Identifiers

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Leader v. 1.0 10/04

Identifier Type: -

Identifier Source: org_study_id

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