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

Ventricular Tachycardia Clinical Trial

— SEPTAL-CRT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00833352
• Other study ID #: SEPTAL CRT 0408
• Status: Completed
• Phase: N/A
• First received: January 30, 2009
• Last updated: January 29, 2014
• Start date: November 2008
• Est. completion date: December 2011

Study information

• Verified date: January 2014
• Source: Guidant Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 263
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure, Systolic
• Systolic Heart Failure
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Fibrillation
• Ventricular Tachycardia

Intervention

Device:
• CRT-D Therapy
Implant of a defibrillator with cardiac resynchronization therapy to detect and terminate ventricular arrhythmias and resynchronize ventricles.

Locations

Country	Name	City	State
France	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	Centre Hospitalier Universitaire de Marseille- Hôpital La Timone	Marseille
France	Hôpital Saint Joseph	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	Vandoeuvre Les Nancy
Spain	Hospital general de Alicante	Alicante
Spain	Hospital Clinic I Provincial	Barcelona
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Hospital Puerta de Hierro	Madrid
Spain	Hospital Universitario Virgen de la Victoria	Málaga
Spain	Hospital Universitario Virgen de Valme	Sevilla
Spain	Hospital Virgen de la salud de Toledo	Toledo
Spain	Hospital La Fe	Valencia
Spain	Hospital Universitario Río Hortega	Valladolid

Sponsors (2)

Lead Sponsor	Collaborator
Guidant Corporation	Boston Scientific Corporation

Countries where clinical trial is conducted

France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	left ventricular end systolic volume (LVESV)		6 months	No
Secondary	left ventricular end systolic volume		12 months	No