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

This study has been completed.
Sponsor:
Information provided by:
Guidant Corporation
ClinicalTrials.gov Identifier:
NCT00180297
First received: September 12, 2005
Last updated: September 10, 2012
Last verified: September 2012
History of Changes
  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 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:

U.S. FDA Resources

Further study details as provided by Guidant Corporation:

Primary Outcome Measures:
  • Implant success rate at septal site [ Time Frame: At implant ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events and effects related to defibrillation lead during 5 year follow-up [ Time Frame: 5 year follow-up ] [ Designated as safety issue: Yes ]
  • Number of successful low energy shocks in VT zone during 1 year follow-up [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Evolution of LVEF [ Time Frame: LVEF over 5 years ] [ Designated as safety issue: No ]
  • Overall adverse events and effects [ Time Frame: 5 years ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Nouvelle Clinique Nantaise
Nantes, France, 34295
CHU Nantes
Nantes, France, 34295
CHU Lariboisière
Paris, France, 75010
HEGP
Paris, France, 75908
CHU Pitié Salpitrière
Paris, France, 75013
Hôpital Pontchaillou
Rennes, France
CHU Rouen
Rouen, France, 76031
CHU Rangueil
Toulouse, France, 31403
CHU Tours
Tours, France, 37044
Sponsors and Collaborators
Guidant Corporation
Investigators
Principal Investigator: Philippe Mabo, MD Hôpital Pontchaillou, Rennes, France
  More Information

No publications provided

Responsible Party: Elisabeth Mouton, Guidant France
ClinicalTrials.gov 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
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on May 16, 2013