NCT00180349

Leader - Evaluation of Endotak Reliance

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 904 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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. 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.

Conditions

• Ventricular Tachycardia
• Ventricular Fibrillation

Interventions

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

Timeline

• Start date: 2004-12-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2005-09-16
• Last updated: 2017-04-14

Locations

25 sites across 1 country: France