Electronic Repositioning With Acuity and Easytrak Leads (ERACE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00610116
Recruitment Status : Completed
First Posted : February 7, 2008
Last Update Posted : February 23, 2017
Information provided by (Responsible Party):
Boston Scientific Corporation

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

Condition or disease Intervention/treatment Phase
Heart Failure Device: Electronic Repositioning Not Applicable

Detailed Description:
"Bipolar leads for left ventricular pacing (LVP) such as the newly available ACUITY TM or the standard EASYTRAK TM II and EASYTRAK TM III leads from GUIDANT in combination with suitable devices for cardiac resynchronisation therapy (CRT) allow for the non-invasive programming of different LVP configurations. Hence, this Electronic RepositioningTM (ER) may help physicians to overcome problems in CRT such as ineffective biventricular pacing, high 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-centre, 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 cardiale resynchronisations therapy (CRT). "

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Electronic Repositioning With Acuity and Easytrak Leads
Study Start Date : September 2006
Actual Primary Completion Date : March 2009
Actual Study Completion Date : September 2009

Arm Intervention/treatment
LV lead electronically repositioning
Single arm study
Device: Electronic Repositioning
Change of pacing vectors for CRT pacing

Primary Outcome Measures :
  1. LVP thresholds and PNS, LVP thresholds in all 4 ER configurations, incidence of high LVP thresholds and PNS, Frequency of use of ER due to high LVP, Handling and stability of anatomic LV lead position, time LV-lead placement and X-ray exposure [ Time Frame: From implant until 6 month follow-up ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients receiving their FIRST implantation of a LV lead in combination with a CRT device with ICD-Backup and the possibility for Electronic Repositioning™
  • Patients willing (= signed written consent) and capable to participate in all procedures of the study"

Exclusion Criteria:

  • Patients who will not be available for routine FU
  • 18 years old
  • Known pregnancy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00610116

University Hospital
Düsseldorf, Germany, 40225
Sponsors and Collaborators
Boston Scientific Corporation

Responsible Party: Boston Scientific Corporation Identifier: NCT00610116     History of Changes
Other Study ID Numbers: C007-CL-106002
First Posted: February 7, 2008    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases