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

Not Applicable

Completed

• Conditions: Ventricular Tachycardia; Ventricular Fibrillation
• Interventions: Device: Endotak Reliance G

• Registration Number: NCT00180297
• Lead Sponsor: Boston Scientific Corporation

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.

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-16
• Status Verified: 2012-09
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Results First Submitted: 2021-06-10
• Results First Submitted QC: 2021-06-10
• Results First Posted: 2021-07-01
• Last Update Submitted: 2021-09-20
• Last Update Posted: 2021-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 215

Inclusion Criteria

• ICD indication according to current Guidelines

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mid septal site location	Endotak Reliance G	RV lead is placed at mid septum.
Apical site location	Endotak Reliance G	RV lead is placed in apical position

Primary Outcome Measures

Name	Time	Method
Implant Success Rate at Septal Site	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 Outcome Measures

Name	Time	Method
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	in VT zone with at least one efficient ATP
- 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	LVEF at 12 months and the change in LVEF at 12 months compared to implant (in %)
Spontaneous Episodes and Therapy Delivery - at Least One Appropriate Treatment	Discharge, 3 Months, 6 Months, 12 Months, 36 Months, 60 Months

Trial Locations

Locations (18)

CHU Henri Mandor; 🇫🇷 Créteil, France

CHU Rangueil; 🇫🇷 Toulouse, France

CHU Tours; 🇫🇷 Tours, France

CH Amiens; 🇫🇷 Amiens, France

CH Besancon; 🇫🇷 Besancon, France

CHU Clermont Ferrand; 🇫🇷 Clermont Ferrand, France

CHU Michalon; 🇫🇷 Grenoble, France

CH St. Joseph; 🇫🇷 Marseille, France

CHU La Timone; 🇫🇷 Marseille, France

Nouvelle Clinique Nantaise; 🇫🇷 Nantes, France

CHU Pitié Salpitrière; 🇫🇷 Paris, France

HEGP; 🇫🇷 Paris, France

Hôpital Pontchaillou; 🇫🇷 Rennes, France

CHU Rouen; 🇫🇷 Rouen, France

CHU Angers; 🇫🇷 Angers, France

CHU Montpellier; 🇫🇷 Montpellier, France

CHU Nantes; 🇫🇷 Nantes, France

CHU Lariboisière; 🇫🇷 Paris, France