NCT00180349

Brief Summary

The objective of this study is to demonstrate the efficacy of the ENDOTAK® RELIANCE™ defibrillation leads connected to a defibrillator or a cardiac resynchronization defibrillator from implant until 12 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
904

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2004

Longer than P75 for all trials

Geographic Reach
1 country

25 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

December 1, 2004

Completed
10 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
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

April 14, 2017

Status Verified

April 1, 2017

Enrollment Period

4.6 years

First QC Date

September 12, 2005

Last Update Submit

April 12, 2017

Conditions

Ventricular TachycardiaVentricular Fibrillation

Outcome Measures

Primary Outcomes (2)

  • Defibrillation testing (DT) procedures and consequences on clinical outcomes

    to determine the DT procedures used in everyday practice, to compare the characteristics of patients with or without DTand to compare severe adverse events in these two populations during implantation

    at implant

  • Defibrillation testing (DT) procedures and consequences on clinical outcomes

    to determine the DT procedures used in everyday practice, to compare the characteristics of patients with or without DTand to compare severe adverse events in these two populations during 1 year follow-up

    during 1 year follow-up

Interventions

Endotak RelianceDEVICE

Endotak Reliance is a defibrillation lead delivering pacing and defibrillation therapy to the ventricle as needed.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients with the indication for an implantable ICD are invited to participate.

You may qualify if:

  • ICD indication according to current guidelines with or without cardiac resynchronization therapy, being implanted with a Guidant ENDOTAK RELIANCE defibrillation lead as first implant, age above 18 years, able to understand the nature of the study and to be available for all follow-ups, having given consent in writing for anonymous data collection, life expectancy \> 1 year.

You may not qualify if:

  • device replacement without concomitant implant of a Reliance defibrillation lead, pregnancy or of birth bearing age without contraception, participation in another clinical study, short life expectancy due to other medical conditions, not willing to sign the consent form, geographically unstable for a defibrillator follow-up as required per protocol, having a ventricular arrhythmia, that can be treated by drugs or surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

CH Amiens

Amiens, 80054, France

Location

CHU Angers

Angers, 49033, France

Location

Hôpital Angoulème

Angoulème, 16470, France

Location

Clinique Cardiologique Aressy

Aressy, 64320, France

Location

CH Avignon

Avignon, 84902, France

Location

CHU du Morvan

Brest, 29609, France

Location

Hôpital Côte de Nacre

Caen, 14033, France

Location

CHU Henri Mondor

Créteil, 94000, France

Location

CHU Michalon

Grenoble, 38043, France

Location

CH Hôpital Nord

Marseille, 13008, France

Location

CHU La Timone

Marseille, 13385, France

Location

CHU Montpellier

Montpellier, 34295, France

Location

CHU Brabois

Nancy, France

Location

Nouvelle Clinique Nantaise

Nantes, 44000, France

Location

CHU Nantes

Nantes, 44295, France

Location

CHU Nice

Nice, 06002, France

Location

CHU D'Orleans

Orléans, 45000, France

Location

Clinique Bizet

Paris, France

Location

CHG Pau

Pau, 64046, France

Location

CHU Pontchaillou

Rennes, 35033, France

Location

CHU Rouen

Rouen, 76031, France

Location

Centre cardiologique du Nord

Saint-Denis, 93000, France

Location

CMC Arnaud Tzanck

Saint-Laurent-du-Var, 6700, France

Location

CHU Rangueil

Toulouse, 31403, France

Location

Clinique St. Gatien

Tours, 37000, France

Location

MeSH Terms

Conditions

Tachycardia, VentricularVentricular Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

  • Nicolas Sadoul, MD

    CHU Brabois, Nancy

    PRINCIPAL INVESTIGATOR

  • Arnaud Lazarus, MD

    Clinique Bizet, Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

December 1, 2004

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

April 14, 2017

Record last verified: 2017-04

Locations

FR(25)