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

Boston Scientific Corporation18 sites in 1 country215 target enrollmentApril 2005

ConditionsVentricular Tachycardia Ventricular Fibrillation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Ventricular Tachycardia
Sponsor: Boston Scientific Corporation
Enrollment: 215
Locations: 18
Primary Endpoint: Implant Success Rate at Septal Site
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2005

End Date

September 2012

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Boston Scientific Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•ICD indication according to current Guidelines

Exclusion Criteria

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

Outcomes

Primary Outcomes

Implant Success Rate at Septal Site

Time Frame: At implant

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 Ω, shock impedance between 29 and 80 Ω and defibrillation at a maximum of 21J.

Secondary Outcomes

Spontaneous Episodes and Therapy Delivery - at Least One Inappropriate Treatment(Discharge, 3 Months, 6 Months, 12 Months, 36 Months, 60 Months)
The Rate of ATP Success Therapy(3 months, 6 months, 12 months, 36 months, 60 months)
- 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)
Evolution of Left Ventricular Ejection Fraction(12 Months)
Spontaneous Episodes and Therapy Delivery - at Least One Appropriate Treatment(Discharge, 3 Months, 6 Months, 12 Months, 36 Months, 60 Months)