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

Condition(s) targeted: Ventricular Tachycardia; Ventricular Fibrillation

Intervention: Endotak Reliance G (Device)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Guidant Corporation

Official(s) and/or principal investigator(s):
Philippe Mabo, MD, Principal Investigator, Affiliation: Hôpital Pontchaillou, Rennes, France

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

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 design: Other, Randomized, Single Blind (Subject), Uncontrolled, Parallel Assignment

Primary outcome: Implant success rate at septal site

Secondary outcome:

Adverse events and effects related to defibrillation lead during 5 year follow-up

Number of successful low energy shocks in VT zone during 1 year follow-up

Evolution of LVEF

Overall adverse events and effects

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- ICD indication according to current Guidelines

Exclusion Criteria:

- Indication for cardiac resynchronisation therapy, absence of spontaneous ventricular

rhythm, pacemaker dependency

Hôpital Pontchaillou, Rennes, France

CHU Michalon, Grenoble 38043, France

CHU Angers, Angers 49033, France

CHU Tours, Tours 37044, France

CHU Montpellier, Montpellier 34295, France

Nouvelle Clinique Nantaise, Nantes 34295, France

CHU Nantes, Nantes 34295, France

CHU Lariboisière, Paris 75010, France

HEGP, Paris 75908, France

CHU Pitié Salpitrière, Paris 75013, France

CHU Rangueil, Toulouse 31403, France

CHU Rouen, Rouen 76031, France

CHU Clermont Ferrand, Clermont Ferrand 63003, France

CHU Henri Mandor, Créteil 94010, France

CHU La Timone, Marseille 13385, France

CH St. Joseph, Marseille 13008, France

CH Amiens, Amiens 80054, France

CH Besancon, Besancon 25030, France

Starting date: April 2005
Ending date: November 2011
Last updated: December 12, 2007