NCT00833352

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. 1.Purpose :
  2. 2.Objectives:

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
263

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2008

Typical duration for not_applicable

Geographic Reach
2 countries

26 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 2, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

January 30, 2014

Status Verified

January 1, 2014

Enrollment Period

3.1 years

First QC Date

January 30, 2009

Last Update Submit

January 29, 2014

Conditions

Systolic Heart FailureVentricular TachycardiaVentricular Fibrillation

Outcome Measures

Primary Outcomes (1)

  • left ventricular end systolic volume (LVESV)

    6 months

Secondary Outcomes (1)

  • left ventricular end systolic volume

    12 months

Study Arms (2)

1

EXPERIMENTAL

Right ventricular lead located in Mid Septum

Device: CRT-D Therapy

2

ACTIVE COMPARATOR

Right ventricular lead located in Apex

Device: CRT-D Therapy

Interventions

CRT-D TherapyDEVICE

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

Also known as: Endotak Reliance G and SG
12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Defibrillation testing not planned during the implant procedure due to a poor haemodynamic or clinical status or other reasons
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Centre Hospitalier Universitaire d'Angers

Angers, 49033, France

Location

Hôpital Louis Pradel

Bron, 69677, France

Location

Centre Hospitalier Universitaire de Grenoble- Hôpital Albert Michalon

Grenoble, 38043, France

Location

Centre Hospitalier Régional Universitaire de Lille

Lille, 59037, France

Location

Hôpital Saint Joseph

Marseille, 13008, France

Location

Centre Hospitalier Universitaire de Marseille- Hôpital La Timone

Marseille, 13385, France

Location

Centre Hospitalier Universitaire de Montpellier- Hôpital Arnaud de Villeneuve

Montpellier, 34295, France

Location

Nouvelles Cliniques Nantaises

Nantes, 44277, France

Location

Centre Hospitalier Régional d'Orléans- Hôpital La Source

Orléans, 45067, France

Location

Hôpital La Pitié Salpétrière

Paris, 75013, France

Location

Centre Hospitalier Universitaire Haut Levêque

Pessac, 33604, France

Location

Centre Hospitaler Universitaire Pontchaillou

Rennes, 35033, France

Location

Centre Hospitalier Universitaire-Charles Nicolle

Rouen, 76031, France

Location

Centre Cardiologique du Nord

Saint-Denis, 93200, France

Location

Centre Hospitalier Universitaire - Hôpital Rangueil

Toulouse, 31059, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

Centre Hospitalier Universitaire de Nancy- Hôpital Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Hospital general de Alicante

Alicante, 03010, Spain

Location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic I Provincial

Barcelona, 08036, Spain

Location

Hospital Puerta de Hierro

Madrid, 28222, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain

Location

Hospital Universitario Virgen de Valme

Seville, 41014, Spain

Location

Hospital Virgen de la salud de Toledo

Toledo, 45004, Spain

Location

Hospital La Fe

Valencia, 46009, Spain

Location

Hospital Universitario Río Hortega

Valladolid, 04710, Spain

Location

Related Publications (1)

  • 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.

    PMID: 26374852DERIVED

MeSH Terms

Conditions

Heart Failure, SystolicTachycardia, VentricularVentricular Fibrillation

Condition Hierarchy (Ancestors)

Heart FailureHeart DiseasesCardiovascular DiseasesTachycardiaArrhythmias, CardiacCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Christophe Leclercq, MD

    Hopital Pontchaillou - Rennes- France

    PRINCIPAL INVESTIGATOR

  • Ignacio Fernández Lozano, MD

    Hospital Puerta de Hierro - Madrid - Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2009

First Posted

February 2, 2009

Study Start

November 1, 2008

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

January 30, 2014

Record last verified: 2014-01

Locations

ES(9)FR(17)