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Electronic Repositioning With Acuity and Easytrak Leads (ERACE)

This study has been completed.
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Guidant Corporation
ClinicalTrials.gov Identifier:
NCT00610116
First received: January 24, 2008
Last updated: September 10, 2012
Last verified: September 2012
  Purpose

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 Intervention
Heart Failure
Device: Electronic Repositioning

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Electronic Repositioning With Acuity and Easytrak Leads

Further study details as provided by Guidant Corporation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: September 2006
Study Completion Date: September 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
LV lead electronically repositioning
Single arm study
Device: Electronic Repositioning
Change of pacing vectors for CRT pacing

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). "

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00610116

Locations
Germany
University Hospital
Düsseldorf, Germany, 40225
Sponsors and Collaborators
Guidant Corporation
Boston Scientific Corporation
  More Information

No publications provided

Responsible Party: Guidant Corporation
ClinicalTrials.gov Identifier: NCT00610116     History of Changes
Other Study ID Numbers: C007-CL-106002
Study First Received: January 24, 2008
Last Updated: September 10, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 27, 2014