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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ventricular Tachycardia, Ventricular Fibrillation

Intervention / Treatment
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* Device: Endotak Reliance G


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mid septal site location<br>RV lead is placed at mid septum. | Device: Endotak Reliance G<br>* Reliance G is a defibrillation lead to be placed in the right ventricle.<br>|
| Active Comparator: Apical site location<br>RV lead is placed in apical position | Device: Endotak Reliance G<br>* Reliance G is a defibrillation lead to be placed in the right ventricle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - 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 | 
| 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 | 
| Spontaneous Episodes and Therapy Delivery - at Least One Appropriate Treatment |  | Discharge, 3 Months, 6 Months, 12 Months, 36 Months, 60 Months | 
| Spontaneous Episodes and Therapy Delivery - at Least One Inappropriate Treatment |  | 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 %) | 12 Months |