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

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

February 19, 2009

Start Date ^ICMJE

April 2005

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Implant success rate at septal site [ Time Frame: At implant ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Implant success rate

Change History

Complete list of historical versions of study NCT00180297 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Adverse events and effects related to defibrillation lead during 5 year follow-up [ Time Frame: 5 year follow-up ] [ Designated as safety issue: Yes ]
Number of successful low energy shocks in VT zone during 1 year follow-up [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Evolution of LVEF [ Time Frame: LVEF over 5 years ] [ Designated as safety issue: No ]
Overall adverse events and effects [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Adverse events and effects related to defibrillation lead during 5 year follow-up
Number of successful low energy shocks in VT zone during 1 year follow-up
Evolution of LVEF
Overall adverse events and effects

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Evaluation of the Success Rate and the Clinical Evolution of a Ventricular Lead Implanted in the Septum Versus the Right Ventricular Apex.

Brief Summary

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

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.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Other, Randomized, Single Blind (Subject), Uncontrolled, Parallel Assignment

Condition ^ICMJE

Ventricular Tachycardia
Ventricular Fibrillation

Intervention ^ICMJE

Device: Endotak Reliance G

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

208

Estimated Completion Date

June 2013

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

ICD indication according to current Guidelines

Exclusion Criteria:

Indication for cardiac resynchronisation therapy, absence of spontaneous ventricular rhythm, pacemaker dependency

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00180297

Responsible Party

Elisabeth Mouton, Guidant France

Study ID Numbers ^ICMJE

Septal 1.1 / 14.04.2005, 2004/12/012

Study Sponsor ^ICMJE

Guidant Corporation

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Philippe Mabo, MD

Hôpital Pontchaillou, Rennes, France

Information Provided By

Guidant Corporation

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP