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Septal - Success Rate and Clinical Outcome of Septal Implant of Ventricular Defibrillation Lead

This study has been completed.
Information provided by:
Guidant Corporation Identifier:
First received: September 12, 2005
Last updated: September 10, 2012
Last verified: September 2012
The purpose of this study is to determine the safety and efficacy of the implant of a ICD lead of defibrillation in the septum of the right ventricle

Condition Intervention Phase
Ventricular Tachycardia
Ventricular Fibrillation
Device: Endotak Reliance G
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Evaluation of the Success Rate and the Clinical Evolution of a Ventricular Lead Implanted in the Septum Versus the Right Ventricular Apex.

Resource links provided by NLM:

Further study details as provided by Guidant Corporation:

Primary Outcome Measures:
  • Implant success rate at septal site [ Time Frame: At implant ]

Secondary Outcome Measures:
  • Adverse events and effects related to defibrillation lead during 5 year follow-up [ Time Frame: 5 year follow-up ]
  • Number of successful low energy shocks in VT zone during 1 year follow-up [ Time Frame: 1 year ]
  • Evolution of LVEF [ Time Frame: LVEF over 5 years ]
  • Overall adverse events and effects [ Time Frame: 5 years ]

Enrollment: 208
Study Start Date: April 2005
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mid septal site vs apical site location
Mid septal site vs apical site location
Device: Endotak Reliance G
Reliance G is a defibrillation lead to be placed in the right ventricle.

Detailed Description:
The rate of success at implant and the positive clinical outcomes for the patients implanted with a lead of defibrillation at the septal site would make it possible to recommend this site as a "new standard" for implant of the defibrillation lead in the RV for ICD.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • ICD indication according to current Guidelines

Exclusion Criteria:

  • Indication for cardiac resynchronisation therapy, absence of spontaneous ventricular rhythm, pacemaker dependency
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00180297

CH Amiens
Amiens, France, 80054
CHU Angers
Angers, France, 49033
CH Besancon
Besancon, France, 25030
CHU Clermont Ferrand
Clermont Ferrand, France, 63003
CHU Henri Mandor
Créteil, France, 94010
CHU Michalon
Grenoble, France, 38043
CH St. Joseph
Marseille, France, 13008
CHU La Timone
Marseille, France, 13385
CHU Montpellier
Montpellier, France, 34295
CHU Nantes
Nantes, France, 34295
Nouvelle Clinique Nantaise
Nantes, France, 34295
CHU Lariboisière
Paris, France, 75010
CHU Pitié Salpitrière
Paris, France, 75013
Paris, France, 75908
Hôpital Pontchaillou
Rennes, France
CHU Rouen
Rouen, France, 76031
CHU Rangueil
Toulouse, France, 31403
CHU Tours
Tours, France, 37044
Sponsors and Collaborators
Guidant Corporation
Principal Investigator: Philippe Mabo, MD Hôpital Pontchaillou, Rennes, France
  More Information

Responsible Party: Elisabeth Mouton, Guidant France Identifier: NCT00180297     History of Changes
Other Study ID Numbers: Septal 1.1 / 14.04.2005  2004/12/012 
Study First Received: September 12, 2005
Last Updated: September 10, 2012

Additional relevant MeSH terms:
Tachycardia, Ventricular
Ventricular Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes processed this record on February 27, 2017