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

NCT00833352 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 263

Last updated 2014-01-30

No results posted yet for this study

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

DEVICE

CRT-D Therapy

Implant of a defibrillator with cardiac resynchronization therapy to detect and terminate ventricular arrhythmias and resynchronize ventricles.

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Guidant Corporation

    lead INDUSTRY

Principal Investigators

  • Christophe Leclercq, MD · Hopital Pontchaillou - Rennes- France

  • Ignacio Fernández Lozano, MD · Hospital Puerta de Hierro - Madrid - Spain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • France
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00833352 on ClinicalTrials.gov