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Completed

NCT Number: NCT00180297

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

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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Key information

Conditions

Ventricular Tachycardia Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular Ventricular Fibrillation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH Amiens, Amiens, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ICD indication according to current Guidelines

Exclusion criteria

  • Indication for cardiac resynchronisation therapy, absence of spontaneous ventricular rhythm, pacemaker dependency

Treatment and study plan

Endotak Reliance G

Device

Reliance G is a defibrillation lead to be placed in the right ventricle.

Primary outcomes

  1. Implant Success Rate at Septal Site

    Time frame: At implant

    Success of implant procedure: 1. implanted at the randomized site; 2. With electric criteria satisfied: pacing threshold < 1.5V, intrinsic amplitude >3 mV, impedance between 450 and 1800 Ω, shock impedance between 29 and 80 Ω and defibrillation at a maximum of 21J.

Secondary outcomes

  1. - The Number of "Low Energy" Shocks (at 11 Joules), Efficient in the VT Zone, in the Population Programmed at This Recommended Value.

    Time frame: 3 months, 6 months, 12 months, 36 months, 60 months

  2. The Rate of ATP Success Therapy

    Time frame: 3 months, 6 months, 12 months, 36 months, 60 months

    in VT zone with at least one efficient ATP

  3. Spontaneous Episodes and Therapy Delivery - at Least One Appropriate Treatment

    Time frame: Discharge, 3 Months, 6 Months, 12 Months, 36 Months, 60 Months

  4. Spontaneous Episodes and Therapy Delivery - at Least One Inappropriate Treatment

    Time frame: Discharge, 3 Months, 6 Months, 12 Months, 36 Months, 60 Months

  5. Evolution of Left Ventricular Ejection Fraction

    Time frame: 12 Months

    LVEF at 12 months and the change in LVEF at 12 months compared to implant (in %)

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Collaborators

  • Guidant Corporation

Registry information

Official study title

Evaluation of the Success Rate and the Clinical Evolution of a Ventricular Lead Implanted in the Septum Versus the Right Ventricular Apex.

Important dates

Study start
2005
Primary completion
2012
Study completion
2012
First posted
Sep 16, 2005
Registry last updated
Oct 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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