Comparison of Right Ventricular Septal and Right Ventricular Apical Pacing in Patients Receiving a CRT-D Device (SEPTAL-CRT)
This study has been completed.
Sponsor:
Guidant Corporation
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Guidant Corporation
ClinicalTrials.gov Identifier:
NCT00833352
First received: January 30, 2009
Last updated: January 29, 2014
Last verified: January 2014
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Systolic Heart Failure Ventricular Tachycardia Ventricular Fibrillation |
Device: CRT-D Therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Comparison of Right Ventricular Septal and Right Ventricular Apical Pacing in Patients Receiving a CRT-D Device |
Resource links provided by NLM:
Further study details as provided by Guidant Corporation:
Primary Outcome Measures:
- left ventricular end systolic volume (LVESV) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- left ventricular end systolic volume [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Enrollment: | 263 |
| Study Start Date: | November 2008 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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).
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00833352
Please refer to this study by its ClinicalTrials.gov identifier: 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 | |
| Centre Hospitalier Universitaire de Marseille- Hôpital La Timone | |
| Marseille, France, 13385 | |
| Hôpital Saint Joseph | |
| Marseille, France, 13008 | |
| 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 Clinic I Provincial | |
| Barcelona, Spain, 08036 | |
| Hospital Vall d'Hebron | |
| Barcelona, Spain, 08035 | |
| 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
No publications provided
| Responsible Party: | Guidant Corporation |
| ClinicalTrials.gov Identifier: | NCT00833352 History of Changes |
| Other Study ID Numbers: | SEPTAL CRT 0408 |
| Study First Received: | January 30, 2009 |
| Last Updated: | January 29, 2014 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Additional relevant MeSH terms:
|
Heart Failure, Systolic Tachycardia, Ventricular Ventricular Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases |
Heart Diseases Heart Failure Pathologic Processes Tachycardia |
ClinicalTrials.gov processed this record on March 03, 2015