Leader - Evaluation of Endotak Reliance

Status Completed

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00180349
Study type	Observational
Source	Boston Scientific Corporation
Contact
Status	Completed
Phase	N/A
Start date	December 2004
Completion date	July 2009

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