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Septal - Success Rate and Clinical Outcome of Septal Implant of Ventricular Defibrillation Lead

NCT ID: NCT00180297

Last Updated: 2021-10-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

215 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2012-09-30

Brief Summary

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The purpose of this study is to determine the safety and efficacy of the implant of a ICD lead of defibrillation in the septum of the right ventricle

Detailed Description

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The rate of success at implant and the positive clinical outcomes for the patients implanted with a lead of defibrillation at the septal site would make it possible to recommend this site as a "new standard" for implant of the defibrillation lead in the RV for ICD.

Conditions

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Ventricular Tachycardia Ventricular Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Mid septal site location

RV lead is placed at mid septum.

Group Type EXPERIMENTAL

Endotak Reliance G

Intervention Type DEVICE

Reliance G is a defibrillation lead to be placed in the right ventricle.

Apical site location

RV lead is placed in apical position

Group Type ACTIVE_COMPARATOR

Endotak Reliance G

Intervention Type DEVICE

Reliance G is a defibrillation lead to be placed in the right ventricle.

Interventions

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Endotak Reliance G

Reliance G is a defibrillation lead to be placed in the right ventricle.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* ICD indication according to current Guidelines

Exclusion Criteria

* Indication for cardiac resynchronisation therapy, absence of spontaneous ventricular rhythm, pacemaker dependency
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guidant Corporation

INDUSTRY

Sponsor Role collaborator

Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philippe Mabo, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Pontchaillou, Rennes, France

Locations

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CH Amiens

Amiens, , France

Site Status

CHU Angers

Angers, , France

Site Status

CH Besancon

Besançon, , France

Site Status

CHU Clermont Ferrand

Clermont-Ferrand, , France

Site Status

CHU Henri Mandor

Créteil, , France

Site Status

CHU Michalon

Grenoble, , France

Site Status

CH St. Joseph

Marseille, , France

Site Status

CHU La Timone

Marseille, , France

Site Status

CHU Montpellier

Montpellier, , France

Site Status

CHU Nantes

Nantes, , France

Site Status

Nouvelle Clinique Nantaise

Nantes, , France

Site Status

CHU Lariboisière

Paris, , France

Site Status

CHU Pitié Salpitrière

Paris, , France

Site Status

HEGP

Paris, , France

Site Status

Hôpital Pontchaillou

Rennes, , France

Site Status

CHU Rouen

Rouen, , France

Site Status

CHU Rangueil

Toulouse, , France

Site Status

CHU Tours

Tours, , France

Site Status

Countries

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France

Other Identifiers

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2004/12/012

Identifier Type: -

Identifier Source: secondary_id

Septal 1.1 / 14.04.2005

Identifier Type: -

Identifier Source: org_study_id