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

January 29, 2014 updated by: Guidant Corporation

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

263

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49033
        • Centre Hospitalier Universitaire d'Angers
      • Bron, France, 69677
        • Hôpital Louis Pradel
      • Grenoble, France, 38043
        • Centre Hospitalier Universitaire de Grenoble- Hôpital Albert Michalon
      • Lille, France, 59037
        • Centre Hospitalier Régional Universitaire de Lille
      • Marseille, France, 13008
        • Hopital Saint Joseph
      • Marseille, France, 13385
        • Centre Hospitalier Universitaire de Marseille- Hôpital La Timone
      • Montpellier, France, 34295
        • Centre Hospitalier Universitaire de Montpellier- Hôpital Arnaud de Villeneuve
      • Nantes, France, 44277
        • Nouvelles Cliniques Nantaises
      • Orléans, France, 45067
        • Centre Hospitalier Régional d'Orléans- Hôpital La Source
      • Paris, France, 75013
        • Hôpital La Pitié Salpêtrière
      • Pessac, France, 33604
        • Centre Hospitalier Universitaire Haut Levêque
      • Rennes, France, 35033
        • Centre Hospitaler Universitaire Pontchaillou
      • Rouen, France, 76031
        • Centre Hospitalier Universitaire-Charles Nicolle
      • Saint Denis, France, 93200
        • Centre Cardiologique Du Nord
      • Toulouse, France, 31076
        • Clinique Pasteur
      • Toulouse, France, 31059
        • Centre Hospitalier Universitaire - Hôpital Rangueil
      • Vandoeuvre Les Nancy, France, 54511
        • Centre Hospitalier Universitaire de Nancy- Hôpital Brabois
  • Spain
      • Alicante, Spain, 03010
        • Hospital General de Alicante
      • Barcelona, Spain, 08035
        • Hospital Vall d'Hebron
      • Barcelona, Spain, 08036
        • Hospital Clinic I Provincial
      • Madrid, Spain, 28222
        • Hospital Puerta de Hierro
      • Málaga, Spain, 29010
        • Hospital Universitario Virgen De La Victoria
      • Sevilla, Spain, 41014
        • Hospital Universitario Virgen de Valme
      • Toledo, Spain, 45004
        • Hospital Virgen de la Salud de Toledo
      • Valencia, Spain, 46009
        • Hospital la Fe
      • Valladolid, Spain, 04710
        • Hospital Universitario Rio Hortega

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Accepted CRT indication according to ESC with

    1. Documented LVEF </= 35% in last 3 months
    2. Documented LVEDD ≥ 55 mm or LVEDD > 30 mm/m2, or LVEDD >30 mm/m (height) in last 3 months
    3. QRS ≥120 ms documented on ECG recording during hospitalisation
    4. NYHA Class III or ambulatory class IV stable for the last month previous enrolment
  • Or the previous criteria 1 and 2 and a transient episode in NYHA class III or IV with prior HF hospitalization or intravenous decongestive therapy (IV diuretics, IV neseritide or IV inotropes) in an "out-patient" setting within the year previous enrolment and stabilization to NYHA class II for the last month with a QRS ≥150 ms documented on ECG recording during hospitalisation
  • ICD indication (class I or II A)
  • Optimal and stable medication for at least one month (except for diuretics stable for minimum 1 week) based on ESC guidelines before the enrolment
  • Chronic heart failure (> 3 months) stable for the last month previous enrolment
  • Stable sinus rhythm at the enrolment
  • Willing and capable of providing informed consent

Exclusion Criteria

  • Defibrillation testing not planned during the implant procedure due to a poor haemodynamic or clinical status or other reasons
  • Have persistent atrial fibrillation (AF) or atrial flutter (i.e, can be terminated with medical intervention, but does not terminate spontaneously) within 1 month prior inclusion
  • Documented AF within 1 month prior enrolment
  • Life expectancy < 12 months or expected to undergo heart transplant within the next 12 months
  • Uncontrolled blood pressure (Systolic BP > 160 mmHg or Diastolic BP > 85 mmHg)
  • Hospitalization for HF or intravenous inotropic drug treatment within 1 month prior enrolment
  • Cardiac surgery, per cutaneous transluminal angioplasty (PTCA), myocardial infarction (MI), unstable or severe angina or stroke during last 3 months prior enrolment
  • Previously implanted pacemaker or ICD
  • Uncorrected primary valvular disease
  • Prosthetic tricuspid valve
  • Nursing women or of childbearing potential who are, or might be pregnant at the time of the study
  • Enrolled in any on-going study (including pharmacologic trial).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Right ventricular lead located in Mid Septum
Device: CRT-D Therapy
Implant of a defibrillator with cardiac resynchronization therapy to detect and terminate ventricular arrhythmias and resynchronize ventricles.
Other Names:
  • Endotak Reliance G and SG
Active Comparator: 2
Right ventricular lead located in Apex
Device: CRT-D Therapy
Implant of a defibrillator with cardiac resynchronization therapy to detect and terminate ventricular arrhythmias and resynchronize ventricles.
Other Names:
  • Endotak Reliance G and SG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
left ventricular end systolic volume (LVESV)
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
left ventricular end systolic volume
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guidant Corporation

Collaborators

Boston Scientific Corporation

Investigators

  • Principal Investigator: Christophe Leclercq, MD, Hopital Pontchaillou - Rennes- France
  • Principal Investigator: Ignacio Fernández Lozano, MD, Hospital Puerta de Hierro - Madrid - Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

January 30, 2009

First Submitted That Met QC Criteria

January 30, 2009

First Posted (Estimate)

February 2, 2009

Study Record Updates

Last Update Posted (Estimate)

January 30, 2014

Last Update Submitted That Met QC Criteria

January 29, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEPTAL CRT 0408

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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