NCT00610116

Electronic Repositioning With Acuity and Easytrak Leads

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 305 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluate appropriate performance of Electronic Repositioning™ (ER) in the clinical routine, cumulative incidence of phrenic nerve stimulation (PNS) \& success rates of Electronic Repositioning (ER) to remove it, various incl. left ventricular pacing (LVP) thresholds and PNS

Detailed description

Bipolar leads for left ventricular pacing (LVP) such as the newly available ACUITY™ or the standard EASYTRAK™ II and EASYTRAK™ III leads from GUIDANT in combination with suitable devices for cardiac resynchronization therapy (CRT) allow for the non-invasive programming of different Left Ventricular Pacing (LVP) configurations. Hence, this Electronic Repositioning (ER) may help physicians to overcome problems in cardiac resynchronization therapy (CRT) such as ineffective biventricular pacing, high Left Ventricular Pacing (LVP) thresholds and phrenic nerve stimulation (PNS) without the need for an additional patient's operation to reposition LV leads. The ERACE study it a multi-center, prospective, non-randomized clinical study to document and evaluate appropriate performance of GUIDANT's Electronic Repositioning™ in the clinical routine with respect to the following major aspects: avoidance of PNS and low LVP thresholds (for low battery consumption and extended device longevity) in standard cardiac resynchronization therapy (CRT)

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	Electronic Repositioning	Change of pacing vectors for CRT pacing

Timeline

• Start date: 2006-09-01
• Primary completion: 2008-03-01
• Completion: 2008-09-01
• First posted: 2008-02-07
• Last updated: 2021-04-21
• Results posted: 2021-02-09

Locations

1 site across 1 country: Germany