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

NCT ID: NCT00833352

Last Updated: 2014-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 263 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2011-12-31

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.

Conditions

Systolic Heart Failure; Ventricular Tachycardia; Ventricular Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

Right ventricular lead located in Mid Septum

Group Type: EXPERIMENTAL

CRT-D Therapy

Intervention Type: DEVICE

Implant of a defibrillator with cardiac resynchronization therapy to detect and terminate ventricular arrhythmias and resynchronize ventricles.

2

Right ventricular lead located in Apex

Group Type: ACTIVE_COMPARATOR

CRT-D Therapy

Intervention Type: DEVICE

Implant of a defibrillator with cardiac resynchronization therapy to detect and terminate ventricular arrhythmias and resynchronize ventricles.

Interventions

CRT-D Therapy

Implant of a defibrillator with cardiac resynchronization therapy to detect and terminate ventricular arrhythmias and resynchronize ventricles.

Intervention Type: DEVICE

Other Intervention Names

Endotak Reliance G and SG

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

Guidant Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christophe Leclercq, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Pontchaillou - Rennes- France

Ignacio Fernández Lozano, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Puerta de Hierro - Madrid - Spain

Locations

Centre Hospitalier Universitaire d'Angers

Angers, , France

Hôpital Louis Pradel

Bron, , France

Centre Hospitalier Universitaire de Grenoble- Hôpital Albert Michalon

Grenoble, , France

Centre Hospitalier Régional Universitaire de Lille

Lille, , France

Hôpital Saint Joseph

Marseille, , France

Centre Hospitalier Universitaire de Marseille- Hôpital La Timone

Marseille, , France

Centre Hospitalier Universitaire de Montpellier- Hôpital Arnaud de Villeneuve

Montpellier, , France

Nouvelles Cliniques Nantaises

Nantes, , France

Centre Hospitalier Régional d'Orléans- Hôpital La Source

Orléans, , France

Hôpital La Pitié Salpétrière

Paris, , France

Centre Hospitalier Universitaire Haut Levêque

Pessac, , France

Centre Hospitaler Universitaire Pontchaillou

Rennes, , France

Centre Hospitalier Universitaire-Charles Nicolle

Rouen, , France

Centre Cardiologique du Nord

Saint-Denis, , France

Centre Hospitalier Universitaire - Hôpital Rangueil

Toulouse, , France

Clinique Pasteur

Toulouse, , France

Centre Hospitalier Universitaire de Nancy- Hôpital Brabois

Vandœuvre-lès-Nancy, , France

Hospital general de Alicante

Alicante, , Spain

Hospital Vall d'Hebron

Barcelona, , Spain

Hospital Clinic I Provincial

Barcelona, , Spain

Hospital Puerta de Hierro

Madrid, , Spain

Hospital Universitario Virgen de la Victoria

Málaga, , Spain

Hospital Universitario Virgen de Valme

Seville, , Spain

Hospital Virgen de la salud de Toledo

Toledo, , Spain

Hospital La Fe

Valencia, , Spain

Hospital Universitario Río Hortega

Valladolid, , Spain

Countries

France; Spain

References

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.

Reference Type: DERIVED

PMID: 26374852 (View on PubMed)

Other Identifiers

SEPTAL CRT 0408

Identifier Type: -

Identifier Source: org_study_id