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Electronic Repositioning With Acuity and Easytrak Leads (ERACE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00610116
First Posted: February 7, 2008
Last Update Posted: February 23, 2017
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.
Information provided by (Responsible Party):
Boston Scientific Corporation
  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: None (Open Label)
Primary Purpose: Treatment
Official Title: Electronic Repositioning With Acuity and Easytrak Leads

Further study details as provided by Boston Scientific 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00610116


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

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00610116     History of Changes
Other Study ID Numbers: C007-CL-106002
First Submitted: January 24, 2008
First Posted: February 7, 2008
Last Update Posted: February 23, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases