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| Descriptive Information Fields | |||||
| Brief Title † | Septal - Success Rate and Clinical Outcome of Septal Implant of Ventricular Defibrillation Lead | ||||
| Official Title † | Evaluation of the Success Rate and the Clinical Evolution of a Ventricular Lead Implanted in the Septum Versus the Right Ventricular Apex. | ||||
| Brief Summary | 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 |
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| 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. |
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| Study Phase | Phase IV | ||||
| Study Type † | Interventional | ||||
| Study Design † | Other, Randomized, Single Blind (Subject), Uncontrolled, Parallel Assignment | ||||
| Primary Outcome Measure † | Implant success rate at septal site [ Time Frame: At implant ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | 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 ] |
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| Condition † | Ventricular Tachycardia Ventricular Fibrillation |
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| Intervention † | Device: Endotak Reliance G | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 208 | ||||
| Start Date † | April 2005 | ||||
| Completion Date | November 2011 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | France | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00180297 | ||||
| Organization ID | Septal 1.1 / 14.04.2005 | ||||
| Secondary IDs †† | 2004/12/012 | ||||
| Study Sponsor † | Guidant Corporation | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Guidant Corporation | ||||
| Verification Date | December 2007 | ||||
| First Received Date † | September 12, 2005 | ||||
| Last Updated Date | December 12, 2007 | ||||
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