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

Boston Scientific Corporation215 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

215

Conditions

Ventricular Tachycardia Ventricular Fibrillation

Interventions

Endotak Reliance GDEVICE

Reliance G is a defibrillation lead to be placed in the right ventricle.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * ICD indication according to current Guidelines Exclusion Criteria: * Indication for cardiac resynchronisation therapy, absence of spontaneous ventricular rhythm, pacemaker dependency

Locations (18)

CH Amiens

Amiens, France

CHU Angers

Angers, France

CH Besancon

Besançon, France

Outcomes

Primary Outcomes

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

Time frame: At implant

Secondary Outcomes

- The Number of "Low Energy" Shocks (at 11 Joules), Efficient in the VT Zone, in the Population Programmed at This Recommended Value.

Time frame: 3 months, 6 months, 12 months, 36 months, 60 months

The Rate of ATP Success Therapy

in VT zone with at least one efficient ATP

Time frame: 3 months, 6 months, 12 months, 36 months, 60 months

Spontaneous Episodes and Therapy Delivery - at Least One Appropriate Treatment

Time frame: Discharge, 3 Months, 6 Months, 12 Months, 36 Months, 60 Months

Spontaneous Episodes and Therapy Delivery - at Least One Inappropriate Treatment

Time frame: Discharge, 3 Months, 6 Months, 12 Months, 36 Months, 60 Months

Evolution of Left Ventricular Ejection Fraction

LVEF at 12 months and the change in LVEF at 12 months compared to implant (in %)

Time frame: 12 Months

Data from ClinicalTrials.gov

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