Status:
COMPLETED
Leader - Evaluation of Endotak Reliance
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Ventricular Tachycardia
Ventricular Fibrillation
Eligibility:
All Genders
18+ years
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 1...
Detailed Description
Baseline and clinical data were collected at inclusion, as were data on procedural characteristics, device implantation-related adverse events and device programming at the time of hospital discharge....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
904 Patients enrolled
Trial Details
Trial ID
NCT00180349
Start Date
December 1 2004
End Date
July 1 2009
Last Update
April 14 2017
Active Locations (25)
Enter a location and click search to find clinical trials sorted by distance.
1
CH Amiens
Amiens, France, 80054
2
CHU Angers
Angers, France, 49033
3
Hôpital Angoulème
Angoulème, France, 16470
4
Clinique Cardiologique Aressy
Aressy, France, 64320