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NCT00180297 Clinical Trial

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

Ventricular Tachycardia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00180297
Other study ID # Septal 1.1 / 14.04.2005
Secondary ID 2004/12/012
Status Completed
Phase N/A
First received
Last updated
Start date April 2005
Est. completion date September 2012

Study information
Verified date September 2012
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 215
Est. completion date September 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - ICD indication according to current Guidelines Exclusion Criteria: - Indication for cardiac resynchronisation therapy, absence of spontaneous ventricular rhythm, pacemaker dependency

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Endotak Reliance G
Reliance G is a defibrillation lead to be placed in the right ventricle.

Locations
Country Name City State
France CH Amiens Amiens
France CHU Angers Angers
France CH Besancon Besancon
France CHU Clermont Ferrand Clermont Ferrand
France CHU Henri Mandor Créteil
France CHU Michalon Grenoble
France CH St. Joseph Marseille
France CHU La Timone Marseille
France CHU Montpellier Montpellier
France CHU Nantes Nantes
France Nouvelle Clinique Nantaise Nantes
France CHU Lariboisière Paris
France CHU Pitié Salpitrière Paris
France HEGP Paris
France Hôpital Pontchaillou Rennes
France CHU Rouen Rouen
France CHU Rangueil Toulouse
France CHU Tours Tours

Sponsors (2)
Lead Sponsor Collaborator
Boston Scientific Corporation Guidant Corporation

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Implant Success Rate at Septal Site Success of implant procedure: 1. implanted at the randomized site; 2. With electric criteria satisfied: pacing threshold < 1.5V, intrinsic amplitude >3 mV, impedance between 450 and 1800 O, shock impedance between 29 and 80 O and defibrillation at a maximum of 21J. At implant
Secondary - The Number of "Low Energy" Shocks (at 11 Joules), Efficient in the VT Zone, in the Population Programmed at This Recommended Value. 3 months, 6 months, 12 months, 36 months, 60 months
Secondary The Rate of ATP Success Therapy in VT zone with at least one efficient ATP 3 months, 6 months, 12 months, 36 months, 60 months
Secondary Spontaneous Episodes and Therapy Delivery - at Least One Appropriate Treatment Discharge, 3 Months, 6 Months, 12 Months, 36 Months, 60 Months
Secondary Spontaneous Episodes and Therapy Delivery - at Least One Inappropriate Treatment Discharge, 3 Months, 6 Months, 12 Months, 36 Months, 60 Months
Secondary Evolution of Left Ventricular Ejection Fraction LVEF at 12 months and the change in LVEF at 12 months compared to implant (in %) 12 Months
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