NCT00833352

Comparison of Right Ventricular Septal and Right Ventricular Apical Pacing in Patients Receiving a CRT-D Device

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 263 (actual)
• Sponsor: Guidant Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective, randomized, single blind, multi-centre study will examine the effect of the right ventricular (RV) lead location in patients implanted with a cardiac resynchronization defibrillator. 1. Purpose : To compare the effect of RV mid-septal (RVS) versus RV apical (RVA) lead location on left ventricular reverse remodeling in patients indicated for cardiac resynchronization therapy device (CRT-D) over a period of 6 months and to evaluate the clinical outcome of the RVS versus RVA pacing, over a period of 12 months. 2. Objectives: The primary objective is to demonstrate that there is no difference between the two groups (RVA vs. RVS) in the change of left ventricular end systolic volume (LVESV), between baseline and 6 months. The secondary objectives are to evaluate the percentage of "echo-responders" plus additional clinical and safety outcomes. This prospective, randomized, multi-centre, single-blind with 2 parallel arms, non-inferiority study will be conducted in approximately 25 study centres in Europe. The patients will be randomized in a 1:1 ratio. A maximum of 416 patients will be enrolled in this study. All eligible patients will be followed through baseline, randomisation, pre discharge, 1, 6 and 12 months post-implant. Enrolment is expected to be completed in 18 months. The total duration of the study is expected to be approximately 30 months.

Conditions

• Systolic Heart Failure
• Ventricular Tachycardia
• Ventricular Fibrillation

Interventions

Type	Name	Description
DEVICE	CRT-D Therapy	Implant of a defibrillator with cardiac resynchronization therapy to detect and terminate ventricular arrhythmias and resynchronize ventricles.

Timeline

• Start date: 2008-11-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2009-02-02
• Last updated: 2014-01-30

Locations

26 sites across 2 countries: France, Spain