Clinical trial NCT00180297: Septal - Success Rate and Clinical Outcome of Septal Implant of Ventricular Defibrillation Lead
Official title: Evaluation of the Success Rate and the Clinical Evolution of a Ventricular Lead Implanted in the Septum Versus the Right Ventricular Apex.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventricular Tachycardia
Ventricular Fibrillation
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
Collaborators: name: Guidant Corporation
First posted: 2005-09-16
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

* ICD indication according to current Guidelines

Exclusion Criteria:

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

Primary outcomes:
measure: Implant Success Rate at Septal Site
timeFrame: At implant
Secondary outcomes:
measure: - The Number of "Low Energy" Shocks (at 11 Joules), Efficient in the VT Zone, in the Population Programmed at This Recommended Value.
timeFrame: 3 months, 6 months, 12 months, 36 months, 60 months
measure: The Rate of ATP Success Therapy
timeFrame: 3 months, 6 months, 12 months, 36 months, 60 months
measure: Spontaneous Episodes and Therapy Delivery - at Least One Appropriate Treatment
timeFrame: Discharge, 3 Months, 6 Months, 12 Months, 36 Months, 60 Months
measure: Spontaneous Episodes and Therapy Delivery - at Least One Inappropriate Treatment
timeFrame: Discharge, 3 Months, 6 Months, 12 Months, 36 Months, 60 Months
measure: Evolution of Left Ventricular Ejection Fraction
timeFrame: 12 Months
Other outcomes:
Locations:
city: Amiens
country: France
facility: CH Amiens
city: Angers
country: France
facility: CHU Angers
city: Besancon
country: France
facility: CH Besancon
city: Clermont Ferrand
country: France
facility: CHU Clermont Ferrand
city: Créteil
country: France
facility: CHU Henri Mandor
city: Grenoble
country: France
facility: CHU Michalon
city: Marseille
country: France
facility: CH St. Joseph
city: Marseille
country: France
facility: CHU La Timone
city: Montpellier
country: France
facility: CHU Montpellier
city: Nantes
country: France
facility: CHU Nantes
city: Nantes
country: France
facility: Nouvelle Clinique Nantaise
city: Paris
country: France
facility: CHU Lariboisière
city: Paris
country: France
facility: CHU Pitié Salpitrière
city: Paris
country: France
facility: HEGP
city: Rennes
country: France
facility: Hôpital Pontchaillou
city: Rouen
country: France
facility: CHU Rouen
city: Toulouse
country: France
facility: CHU Rangueil
city: Tours
country: France
facility: CHU Tours
Study officials:
affiliation: Hôpital Pontchaillou, Rennes, France
name: Philippe Mabo, MD
role: PRINCIPAL_INVESTIGATOR
References: