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

Sponsor

Guidant Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT00833352

Collaborator

Boston Scientific Corporation (Industry)

263

Enrollment

Locations

Arms

Duration (Months)

10.1

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Systolic Heart Failure Ventricular Tachycardia Ventricular Fibrillation	Device: CRT-D Therapy	N/A

Study Design

Study Type:

Interventional

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 :

Nov 1, 2008

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

left ventricular end systolic volume (LVESV) [6 months]

Secondary Outcome Measures

left ventricular end systolic volume [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	Centre Hospitalier Universitaire d'Angers	Angers	France	49033
2	Hôpital Louis Pradel	Bron	France	69677
3	Centre Hospitalier Universitaire de Grenoble- Hôpital Albert Michalon	Grenoble	France	38043
4	Centre Hospitalier Régional Universitaire de Lille	Lille	France	59037
5	Hôpital Saint Joseph	Marseille	France	13008
6	Centre Hospitalier Universitaire de Marseille- Hôpital La Timone	Marseille	France	13385
7	Centre Hospitalier Universitaire de Montpellier- Hôpital Arnaud de Villeneuve	Montpellier	France	34295
8	Nouvelles Cliniques Nantaises	Nantes	France	44277
9	Centre Hospitalier Régional d'Orléans- Hôpital La Source	Orléans	France	45067
10	Hôpital La Pitié Salpétrière	Paris	France	75013
11	Centre Hospitalier Universitaire Haut Levêque	Pessac	France	33604
12	Centre Hospitaler Universitaire Pontchaillou	Rennes	France	35033
13	Centre Hospitalier Universitaire-Charles Nicolle	Rouen	France	76031
14	Centre Cardiologique du Nord	Saint Denis	France	93200
15	Centre Hospitalier Universitaire - Hôpital Rangueil	Toulouse	France	31059
16	Clinique Pasteur	Toulouse	France	31076
17	Centre Hospitalier Universitaire de Nancy- Hôpital Brabois	Vandoeuvre Les Nancy	France	54511
18	Hospital general de Alicante	Alicante	Spain	03010
19	Hospital Vall d'Hebron	Barcelona	Spain	08035
20	Hospital Clinic I Provincial	Barcelona	Spain	08036
21	Hospital Puerta de Hierro	Madrid	Spain	28222
22	Hospital Universitario Virgen de la Victoria	Málaga	Spain	29010
23	Hospital Universitario Virgen de Valme	Sevilla	Spain	41014
24	Hospital Virgen de la salud de Toledo	Toledo	Spain	45004
25	Hospital La Fe	Valencia	Spain	46009
26	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