Clinical trial NCT00833352: Comparison of Right Ventricular Septal and Right Ventricular Apical Pacing in Patients Receiving a CRT-D Device
Official title: Comparison of Right Ventricular Septal and Right Ventricular Apical Pacing in Patients Receiving a CRT-D Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systolic Heart Failure
Ventricular Tachycardia
Ventricular Fibrillation
Lead sponsor: Guidant Corporation
Sponsor class: INDUSTRY
Collaborators: name: Boston Scientific Corporation
First posted: 2009-02-02
Enrollment: 263
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: left ventricular end systolic volume (LVESV)
timeFrame: 6 months
Secondary outcomes:
measure: left ventricular end systolic volume
timeFrame: 12 months
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre Hospitalier Universitaire d'Angers
city: Bron
country: France
facility: Hôpital Louis Pradel
city: Grenoble
country: France
facility: Centre Hospitalier Universitaire de Grenoble- Hôpital Albert Michalon
city: Lille
country: France
facility: Centre Hospitalier Régional Universitaire de Lille
city: Marseille
country: France
facility: Hôpital Saint Joseph
city: Marseille
country: France
facility: Centre Hospitalier Universitaire de Marseille- Hôpital La Timone
city: Montpellier
country: France
facility: Centre Hospitalier Universitaire de Montpellier- Hôpital Arnaud de Villeneuve
city: Nantes
country: France
facility: Nouvelles Cliniques Nantaises
city: Orléans
country: France
facility: Centre Hospitalier Régional d'Orléans- Hôpital La Source
city: Paris
country: France
facility: Hôpital La Pitié Salpétrière
city: Pessac
country: France
facility: Centre Hospitalier Universitaire Haut Levêque
city: Rennes
country: France
facility: Centre Hospitaler Universitaire Pontchaillou
city: Rouen
country: France
facility: Centre Hospitalier Universitaire-Charles Nicolle
city: Saint Denis
country: France
facility: Centre Cardiologique du Nord
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire - Hôpital Rangueil
city: Toulouse
country: France
facility: Clinique Pasteur
city: Vandoeuvre Les Nancy
country: France
facility: Centre Hospitalier Universitaire de Nancy- Hôpital Brabois
city: Alicante
country: Spain
facility: Hospital general de Alicante
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial
city: Madrid
country: Spain
facility: Hospital Puerta de Hierro
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de Valme
city: Toledo
country: Spain
facility: Hospital Virgen de la salud de Toledo
city: Valencia
country: Spain
facility: Hospital La Fe
city: Valladolid
country: Spain
facility: Hospital Universitario Río Hortega
Study officials:
affiliation: Hopital Pontchaillou - Rennes- France
name: Christophe Leclercq, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Puerta de Hierro - Madrid - Spain
name: Ignacio Fernández Lozano, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.