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

Primary Purpose

Ventricular Tachycardia, Ventricular Fibrillation

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Endotak Reliance G
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Ventricular Tachycardia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ICD indication according to current Guidelines Exclusion Criteria: Indication for cardiac resynchronisation therapy, absence of spontaneous ventricular rhythm, pacemaker dependency

Sites / Locations

  • CH Amiens
  • CHU Angers
  • CH Besancon
  • CHU Clermont Ferrand
  • CHU Henri Mandor
  • CHU Michalon
  • CH St. Joseph
  • CHU La Timone
  • CHU Montpellier
  • CHU Nantes
  • Nouvelle Clinique Nantaise
  • CHU Lariboisière
  • CHU Pitié Salpitrière
  • HEGP
  • Hôpital Pontchaillou
  • CHU Rouen
  • CHU Rangueil
  • CHU Tours

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mid septal site location

Apical site location

Arm Description

RV lead is placed at mid septum.

RV lead is placed in apical position

Outcomes

Primary Outcome Measures

Implant Success Rate at Septal Site
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 Outcome Measures

- The Number of "Low Energy" Shocks (at 11 Joules), Efficient in the VT Zone, in the Population Programmed at This Recommended Value.
The Rate of ATP Success Therapy
in VT zone with at least one efficient ATP
Spontaneous Episodes and Therapy Delivery - at Least One Appropriate Treatment
Spontaneous Episodes and Therapy Delivery - at Least One Inappropriate Treatment
Evolution of Left Ventricular Ejection Fraction
LVEF at 12 months and the change in LVEF at 12 months compared to implant (in %)

Full Information

First Posted
September 12, 2005
Last Updated
September 20, 2021
Sponsor
Boston Scientific Corporation
Collaborators
Guidant Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00180297
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
Collaborators
Guidant Corporation

4. Oversight

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia, Ventricular Fibrillation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
215 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mid septal site location
Arm Type
Experimental
Arm Description
RV lead is placed at mid septum.
Arm Title
Apical site location
Arm Type
Active Comparator
Arm Description
RV lead is placed in apical position
Intervention Type
Device
Intervention Name(s)
Endotak Reliance G
Intervention Description
Reliance G is a defibrillation lead to be placed in the right ventricle.
Primary Outcome Measure Information:
Title
Implant Success Rate at Septal Site
Description
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.
Time Frame
At implant
Secondary Outcome Measure Information:
Title
- 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
Title
The Rate of ATP Success Therapy
Description
in VT zone with at least one efficient ATP
Time Frame
3 months, 6 months, 12 months, 36 months, 60 months
Title
Spontaneous Episodes and Therapy Delivery - at Least One Appropriate Treatment
Time Frame
Discharge, 3 Months, 6 Months, 12 Months, 36 Months, 60 Months
Title
Spontaneous Episodes and Therapy Delivery - at Least One Inappropriate Treatment
Time Frame
Discharge, 3 Months, 6 Months, 12 Months, 36 Months, 60 Months
Title
Evolution of Left Ventricular Ejection Fraction
Description
LVEF at 12 months and the change in LVEF at 12 months compared to implant (in %)
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ICD indication according to current Guidelines Exclusion Criteria: Indication for cardiac resynchronisation therapy, absence of spontaneous ventricular rhythm, pacemaker dependency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Mabo, MD
Organizational Affiliation
Hôpital Pontchaillou, Rennes, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
CHU Angers
City
Angers
ZIP/Postal Code
49033
Country
France
Facility Name
CH Besancon
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
CHU Clermont Ferrand
City
Clermont Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
CHU Henri Mandor
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
CHU Michalon
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
CH St. Joseph
City
Marseille
ZIP/Postal Code
13008
Country
France
Facility Name
CHU La Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
CHU Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHU Nantes
City
Nantes
ZIP/Postal Code
34295
Country
France
Facility Name
Nouvelle Clinique Nantaise
City
Nantes
ZIP/Postal Code
34295
Country
France
Facility Name
CHU Lariboisière
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
CHU Pitié Salpitrière
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
HEGP
City
Paris
ZIP/Postal Code
75908
Country
France
Facility Name
Hôpital Pontchaillou
City
Rennes
Country
France
Facility Name
CHU Rouen
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
CHU Rangueil
City
Toulouse
ZIP/Postal Code
31403
Country
France
Facility Name
CHU Tours
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

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

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