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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00180349
Other study ID # Leader v. 1.0 10/04
Secondary ID
Status Completed
Phase N/A
First received September 12, 2005
Last updated April 12, 2017
Start date December 2004
Est. completion date July 2009

Study information

Verified date April 2017
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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. Patients were subsequently divided in two groups: patients who underwent VF induction at implantation or before hospital discharge(VF induction group); and patients who did not undergo VF induction (untested group).The patients were followed up at 3—6 months and at12 months after the implantation. VF induction procedures were left to the investigator's discretion, but reasons for not performing a VF induction at implantation were recorded prospectively. ICD programming parameters for tachycardia or bradycardia were also left at the investigator's discretion.


Recruitment information / eligibility

Status Completed
Enrollment 904
Est. completion date July 2009
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
France CH Amiens Amiens
France CHU Angers Angers
France Hôpital Angoulème Angoulème
France Clinique Cardiologique Aressy Aressy
France CH Avignon Avignon
France CHU du Morvan Brest
France Hôpital Côte de Nacre Caen
France CHU Henri Mondor Créteil
France CHU Michalon Grenoble
France CH Hôpital Nord Marseille
France CHU La Timone Marseille
France CHU Montpellier Montpellier
France CHU Brabois Nancy
France CHU Nantes Nantes
France Nouvelle Clinique Nantaise Nantes
France CHU Nice Nice
France CHU D'Orleans Orleans
France Clinique Bizet Paris
France CHG Pau Pau
France CHU Pontchaillou Rennes
France CHU Rouen Rouen
France Centre cardiologique du Nord St. Denis
France CMC Arnaud Tzanck St. Laurent du Var
France CHU Rangueil Toulouse
France Clinique St. Gatien Tours

Sponsors (1)

Lead Sponsor Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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