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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT00180349 |
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Date of registration:
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12/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Leader - Evaluation of Endotak Reliance
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Scientific title:
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Short and Long Term Evaluation of Electrical Measurements and Defibrillation Energies, Results of ATP and Diagnostic Functions of Devices Connected to Endotak RELIANCE® Defibrillation Leads |
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Date of first enrolment:
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December 2004 |
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Target sample size:
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904 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00180349 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Nicolas Sadoul, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHU Brabois, Nancy |
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Name:
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Arnaud Lazarus, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Clinique Bizet, Paris |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ventricular Fibrillation
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Ventricular Tachycardia
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Intervention(s)
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Device: Endotak Reliance
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Primary Outcome(s)
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Defibrillation testing (DT) procedures and consequences on clinical outcomes
[Time Frame: at implant]
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Defibrillation testing (DT) procedures and consequences on clinical outcomes
[Time Frame: during 1 year follow-up]
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Secondary ID(s)
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Leader v. 1.0 10/04
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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