Ventricular Tachycardia Clinical Trial
Official title:
Comparison of Right Ventricular Septal and Right Ventricular Apical Pacing in Patients Receiving a CRT-D Device
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.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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