NCT00180297

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
215

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
8.8 years until next milestone

Results Posted

Study results publicly available

July 1, 2021

Completed
Last Updated

October 14, 2021

Status Verified

September 1, 2012

Enrollment Period

7.4 years

First QC Date

September 12, 2005

Results QC Date

June 10, 2021

Last Update Submit

September 20, 2021

Conditions

Ventricular TachycardiaVentricular Fibrillation

Outcome Measures

Primary Outcomes (1)

  • 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.

    At implant

Secondary Outcomes (5)

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

    3 months, 6 months, 12 months, 36 months, 60 months

  • The Rate of ATP Success Therapy

    3 months, 6 months, 12 months, 36 months, 60 months

  • Spontaneous Episodes and Therapy Delivery - at Least One Appropriate Treatment

    Discharge, 3 Months, 6 Months, 12 Months, 36 Months, 60 Months

  • Spontaneous Episodes and Therapy Delivery - at Least One Inappropriate Treatment

    Discharge, 3 Months, 6 Months, 12 Months, 36 Months, 60 Months

  • Evolution of Left Ventricular Ejection Fraction

    12 Months

Study Arms (2)

Mid septal site location

EXPERIMENTAL

RV lead is placed at mid septum.

Device: Endotak Reliance G

Apical site location

ACTIVE COMPARATOR

RV lead is placed in apical position

Device: Endotak Reliance G

Interventions

Endotak Reliance GDEVICE

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

Apical site locationMid septal site location

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ICD indication according to current Guidelines

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

CH Amiens

Amiens, 80054, France

Location

CHU Angers

Angers, 49033, France

Location

CH Besancon

Besançon, 25030, France

Location

CHU Clermont Ferrand

Clermont-Ferrand, 63003, France

Location

CHU Henri Mandor

Créteil, 94010, France

Location

CHU Michalon

Grenoble, 38043, France

Location

CH St. Joseph

Marseille, 13008, France

Location

CHU La Timone

Marseille, 13385, France

Location

CHU Montpellier

Montpellier, 34295, France

Location

CHU Nantes

Nantes, 34295, France

Location

Nouvelle Clinique Nantaise

Nantes, 34295, France

Location

CHU Lariboisière

Paris, 75010, France

Location

CHU Pitié Salpitrière

Paris, 75013, France

Location

HEGP

Paris, 75908, France

Location

Hôpital Pontchaillou

Rennes, France

Location

CHU Rouen

Rouen, 76031, France

Location

CHU Rangueil

Toulouse, 31403, France

Location

CHU Tours

Tours, 37044, France

Location

MeSH Terms

Conditions

Tachycardia, VentricularVentricular Fibrillation

Condition Hierarchy (Ancestors)

TachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Elisabeth Mouton - Clinical Trial Manager
Organization
Boston Scientific
elisabeth.mouton@bsci.com
+33 1 39 30 11 90

Study Officials

  • Philippe Mabo, MD

    Hôpital Pontchaillou, Rennes, France

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

April 1, 2005

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

October 14, 2021

Results First Posted

July 1, 2021

Record last verified: 2012-09

Locations

FR(18)