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

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ClinicalTrials.gov Identifier: NCT00833352
Recruitment Status : Completed
First Posted : February 2, 2009
Last Update Posted : January 30, 2014
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Guidant Corporation

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Systolic Heart Failure Ventricular Tachycardia Ventricular Fibrillation Device: CRT-D Therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 263 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Right Ventricular Septal and Right Ventricular Apical Pacing in Patients Receiving a CRT-D Device
Study Start Date : November 2008
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: Endotak Reliance G and SG


Outcome Measures
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Primary Outcome Measures :
  1. left ventricular end systolic volume (LVESV) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. left ventricular end systolic volume [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00833352


Locations
France
Centre Hospitalier Universitaire d'Angers
Angers, France, 49033
Hôpital Louis Pradel
Bron, France, 69677
Centre Hospitalier Universitaire de Grenoble- Hôpital Albert Michalon
Grenoble, France, 38043
Centre Hospitalier Régional Universitaire de Lille
Lille, France, 59037
Hôpital Saint Joseph
Marseille, France, 13008
Centre Hospitalier Universitaire de Marseille- Hôpital La Timone
Marseille, France, 13385
Centre Hospitalier Universitaire de Montpellier- Hôpital Arnaud de Villeneuve
Montpellier, France, 34295
Nouvelles Cliniques Nantaises
Nantes, France, 44277
Centre Hospitalier Régional d'Orléans- Hôpital La Source
Orléans, France, 45067
Hôpital La Pitié Salpétrière
Paris, France, 75013
Centre Hospitalier Universitaire Haut Levêque
Pessac, France, 33604
Centre Hospitaler Universitaire Pontchaillou
Rennes, France, 35033
Centre Hospitalier Universitaire-Charles Nicolle
Rouen, France, 76031
Centre Cardiologique du Nord
Saint Denis, France, 93200
Centre Hospitalier Universitaire - Hôpital Rangueil
Toulouse, France, 31059
Clinique Pasteur
Toulouse, France, 31076
Centre Hospitalier Universitaire de Nancy- Hôpital Brabois
Vandoeuvre Les Nancy, France, 54511
Spain
Hospital general de Alicante
Alicante, Spain, 03010
Hospital Vall d'Hebron
Barcelona, Spain, 08035
Hospital Clinic I Provincial
Barcelona, Spain, 08036
Hospital Puerta de Hierro
Madrid, Spain, 28222
Hospital Universitario Virgen de la Victoria
Málaga, Spain, 29010
Hospital Universitario Virgen de Valme
Sevilla, Spain, 41014
Hospital Virgen de la salud de Toledo
Toledo, Spain, 45004
Hospital La Fe
Valencia, Spain, 46009
Hospital Universitario Río Hortega
Valladolid, Spain, 04710
Sponsors and Collaborators
Guidant Corporation
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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Guidant Corporation
ClinicalTrials.gov Identifier: NCT00833352     History of Changes
Other Study ID Numbers: SEPTAL CRT 0408
First Posted: February 2, 2009    Key Record Dates
Last Update Posted: January 30, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Heart Failure
Tachycardia
Tachycardia, Ventricular
Ventricular Fibrillation
Heart Failure, Systolic
 Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes