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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
263
Implant of a defibrillator with cardiac resynchronization therapy to detect and terminate ventricular arrhythmias and resynchronize ventricles.
Centre Hospitalier Universitaire d'Angers
Angers, France
Hôpital Louis Pradel
Bron, France
Centre Hospitalier Universitaire de Grenoble- Hôpital Albert Michalon
Grenoble, France
Centre Hospitalier Régional Universitaire de Lille
Lille, France
Hôpital Saint Joseph
Marseille, France
Centre Hospitalier Universitaire de Marseille- Hôpital La Timone
Marseille, France
Centre Hospitalier Universitaire de Montpellier- Hôpital Arnaud de Villeneuve
Montpellier, France
Nouvelles Cliniques Nantaises
Nantes, France
Centre Hospitalier Régional d'Orléans- Hôpital La Source
Orléans, France
Hôpital La Pitié Salpétrière
Paris, France
...and 16 more locations
left ventricular end systolic volume (LVESV)
Time frame: 6 months
left ventricular end systolic volume
Time frame: 12 months
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