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

Boston Scientific

Status: Completed

Conditions: Ventricular Fibrillation; Ventricular Tachycardia

Treatments: Device: Endotak Reliance G

Study type: Interventional

Funder types: Industry

Identifiers

NCT00180297

Septal 1.1 / 14.04.2005

2004/12/012

Details and patient eligibility

About

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

Full 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.

Enrollment: 215 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ICD indication according to current Guidelines

Exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

215 participants in 2 patient groups

Mid septal site location

Experimental group

Description:

RV lead is placed at mid septum.

Treatment:

Device: Endotak Reliance G

Apical site location

Active Comparator group

Description:

RV lead is placed in apical position

Treatment:

Device: Endotak Reliance G