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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00180297
First Posted: September 16, 2005
Last Update Posted: February 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Guidant Corporation
Information provided by (Responsible Party):
Boston Scientific Corporation
  Purpose
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
Ventricular Tachycardia Ventricular Fibrillation Device: Endotak Reliance G

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
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 Boston Scientific 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
Experimental: Mid septal site location
RV lead is placed at mid septum.
Device: Endotak Reliance G
Reliance G is a defibrillation lead to be placed in the right ventricle.
Active Comparator: Apical site location
RV lead is placed in apical position
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.
  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00180297


Locations
France
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
HEGP
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
Boston Scientific Corporation
Guidant Corporation
Investigators
Principal Investigator: Philippe Mabo, MD Hôpital Pontchaillou, Rennes, France
  More Information

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00180297     History of Changes
Other Study ID Numbers: Septal 1.1 / 14.04.2005
2004/12/012
First Submitted: September 12, 2005
First Posted: September 16, 2005
Last Update Posted: February 28, 2017
Last Verified: September 2012

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Ventricular
Ventricular Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes