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

Sponsored by:	Guidant Corporation
Information provided by:	Guidant Corporation
ClinicalTrials.gov Identifier:	NCT00180297

Purpose

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

Condition	Intervention	Phase
Ventricular Tachycardia Ventricular Fibrillation	Device: Endotak Reliance G	Phase IV

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Single Blind (Subject), Uncontrolled, Parallel Assignment
Official Title:	Evaluation of the Success Rate and the Clinical Evolution of a Ventricular Lead Implanted in the Septum Versus the Right Ventricular Apex.

Further study details as provided by Guidant Corporation:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Enrollment:	208
Study Start Date:	April 2005
Estimated Study Completion Date:	November 2011

Intervention Details:

Reliance G is a defibrillation lead to be placed in 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

ICD indication according to current Guidelines

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00180297

Locations

France
Hôpital Pontchaillou
Rennes, France
CHU Michalon
Grenoble, France, 38043
CHU Angers
Angers, France, 49033
CHU Tours
Tours, France, 37044
CHU Montpellier
Montpellier, France, 34295
Nouvelle Clinique Nantaise
Nantes, France, 34295
CHU Nantes
Nantes, France, 34295
CHU Lariboisière
Paris, France, 75010
HEGP
Paris, France, 75908
CH Besancon
Besancon, France, 25030
CHU Rangueil
Toulouse, France, 31403
CHU Rouen
Rouen, France, 76031
CHU Clermont Ferrand
Clermont Ferrand, France, 63003
CHU Henri Mandor
Créteil, France, 94010
CHU La Timone
Marseille, France, 13385
CH St. Joseph
Marseille, France, 13008
CH Amiens
Amiens, France, 80054
CHU Pitié Salpitrière
Paris, France, 75013

Sponsors and Collaborators

Guidant Corporation

Investigators

Principal Investigator:

Philippe Mabo, MD

Hôpital Pontchaillou, Rennes, France

More Information

Responsible Party:	Guidant France ( Elisabeth Mouton )
Study ID Numbers:	Septal 1.1 / 14.04.2005, 2004/12/012
Study First Received:	September 12, 2005
Last Updated:	December 12, 2007
ClinicalTrials.gov Identifier:	NCT00180297
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Heart Diseases
Tachycardia
Paroxysmal ventricular fibrillation

Tachycardia, Ventricular
Ventricular Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009