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

Primary Purpose

Systolic Heart Failure, Ventricular Tachycardia, Ventricular Fibrillation

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
CRT-D Therapy
Sponsored by
Guidant Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systolic Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Centre Hospitalier Universitaire d'Angers
  • Hôpital Louis Pradel
  • Centre Hospitalier Universitaire de Grenoble- Hôpital Albert Michalon
  • Centre Hospitalier Régional Universitaire de Lille
  • Hôpital Saint Joseph
  • Centre Hospitalier Universitaire de Marseille- Hôpital La Timone
  • Centre Hospitalier Universitaire de Montpellier- Hôpital Arnaud de Villeneuve
  • Nouvelles Cliniques Nantaises
  • Centre Hospitalier Régional d'Orléans- Hôpital La Source
  • Hôpital La Pitié Salpétrière
  • Centre Hospitalier Universitaire Haut Levêque
  • Centre Hospitaler Universitaire Pontchaillou
  • Centre Hospitalier Universitaire-Charles Nicolle
  • Centre Cardiologique du Nord
  • Centre Hospitalier Universitaire - Hôpital Rangueil
  • Clinique Pasteur
  • Centre Hospitalier Universitaire de Nancy- Hôpital Brabois
  • Hospital general de Alicante
  • Hospital Vall d'Hebron
  • Hospital Clinic I Provincial
  • Hospital Puerta de Hierro
  • Hospital Universitario Virgen de la Victoria
  • Hospital Universitario Virgen de Valme
  • Hospital Virgen de la salud de Toledo
  • Hospital La Fe
  • Hospital Universitario Río Hortega

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Right ventricular lead located in Mid Septum

Right ventricular lead located in Apex

Outcomes

Primary Outcome Measures

left ventricular end systolic volume (LVESV)

Secondary Outcome Measures

left ventricular end systolic volume

Full Information

First Posted
January 30, 2009
Last Updated
January 29, 2014
Sponsor
Guidant Corporation
Collaborators
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00833352
Brief Title
Comparison of Right Ventricular Septal and Right Ventricular Apical Pacing in Patients Receiving a CRT-D Device
Acronym
SEPTAL-CRT
Official Title
Comparison of Right Ventricular Septal and Right Ventricular Apical Pacing in Patients Receiving a CRT-D Device
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guidant Corporation
Collaborators
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systolic Heart Failure, Ventricular Tachycardia, Ventricular Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
263 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Right ventricular lead located in Mid Septum
Arm Title
2
Arm Type
Active Comparator
Arm Description
Right ventricular lead located in Apex
Intervention Type
Device
Intervention Name(s)
CRT-D Therapy
Other Intervention Name(s)
Endotak Reliance G and SG
Intervention Description
Implant of a defibrillator with cardiac resynchronization therapy to detect and terminate ventricular arrhythmias and resynchronize ventricles.
Primary Outcome Measure Information:
Title
left ventricular end systolic volume (LVESV)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
left ventricular end systolic volume
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Accepted CRT indication according to ESC with Documented LVEF </= 35% in last 3 months Documented LVEDD ≥ 55 mm or LVEDD > 30 mm/m2, or LVEDD >30 mm/m (height) in last 3 months QRS ≥120 ms documented on ECG recording during hospitalisation 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe Leclercq, MD
Organizational Affiliation
Hopital Pontchaillou - Rennes- France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ignacio Fernández Lozano, MD
Organizational Affiliation
Hospital Puerta de Hierro - Madrid - Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire d'Angers
City
Angers
ZIP/Postal Code
49033
Country
France
Facility Name
Hôpital Louis Pradel
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
Centre Hospitalier Universitaire de Grenoble- Hôpital Albert Michalon
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Centre Hospitalier Régional Universitaire de Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hôpital Saint Joseph
City
Marseille
ZIP/Postal Code
13008
Country
France
Facility Name
Centre Hospitalier Universitaire de Marseille- Hôpital La Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Centre Hospitalier Universitaire de Montpellier- Hôpital Arnaud de Villeneuve
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Nouvelles Cliniques Nantaises
City
Nantes
ZIP/Postal Code
44277
Country
France
Facility Name
Centre Hospitalier Régional d'Orléans- Hôpital La Source
City
Orléans
ZIP/Postal Code
45067
Country
France
Facility Name
Hôpital La Pitié Salpétrière
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Centre Hospitalier Universitaire Haut Levêque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Centre Hospitaler Universitaire Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Centre Hospitalier Universitaire-Charles Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Centre Cardiologique du Nord
City
Saint Denis
ZIP/Postal Code
93200
Country
France
Facility Name
Centre Hospitalier Universitaire - Hôpital Rangueil
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Clinique Pasteur
City
Toulouse
ZIP/Postal Code
31076
Country
France
Facility Name
Centre Hospitalier Universitaire de Nancy- Hôpital Brabois
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Hospital general de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic I Provincial
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Puerta de Hierro
City
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Universitario Virgen de la Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Virgen de Valme
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Hospital Virgen de la salud de Toledo
City
Toledo
ZIP/Postal Code
45004
Country
Spain
Facility Name
Hospital La Fe
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Hospital Universitario Río Hortega
City
Valladolid
ZIP/Postal Code
04710
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
26374852
Citation
Leclercq C, Sadoul N, Mont L, Defaye P, Osca J, Mouton E, Isnard R, Habib G, Zamorano J, Derumeaux G, Fernandez-Lozano I; SEPTAL CRT Study Investigators. Comparison of right ventricular septal pacing and right ventricular apical pacing in patients receiving cardiac resynchronization therapy defibrillators: the SEPTAL CRT Study. Eur Heart J. 2016 Feb 1;37(5):473-83. doi: 10.1093/eurheartj/ehv422. Epub 2015 Sep 15.
Results Reference
derived

Learn more about this trial

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

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