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

This study has been completed.
Sponsor:
Collaborator:
Guidant Corporation
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00180297
First received: September 12, 2005
Last updated: February 24, 2017
Last verified: September 2012
  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: 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

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
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 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
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
Study First Received: September 12, 2005
Last Updated: February 24, 2017

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

ClinicalTrials.gov processed this record on June 27, 2017