Electronic Repositioning With Acuity and Easytrak Leads (ERACE)
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Electronic Repositioning
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Patients receiving their FIRST implantation of a Left Ventricular (LV) lead in combination with a CRT device with implantable cardioverter defibrillator (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 Follow up
- 18 years old
- Known pregnancy.
Sites / Locations
- University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
LV lead electronically repositioning
Arm Description
Single arm study
Outcomes
Primary Outcome Measures
Proportion of Patients Without the Occurrence of Cardiac Resynchronization Therapy (CRT)-Induced Phrenic Nerve Stimulation (PNS) Between Implant and First Regular Follow-up (FU)
The primary endpoint was the percentage of patients in whom PNS induced by Left Ventricular (LV) pacing could be avoided by electronic repositioning from implantation to first regular follow up (3-6 months postimplant). In this evaluation, prevention of PNS was defined as PNS appearing with the standard pacing configuration-LV tip as cathode versus Right Ventricle (RV) coil as anode-and being avoided by at least one of the three alternative reprogrammable configurations.
Secondary Outcome Measures
Full Information
NCT ID
NCT00610116
First Posted
January 24, 2008
Last Updated
March 30, 2021
Sponsor
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00610116
Brief Title
Electronic Repositioning With Acuity and Easytrak Leads
Acronym
ERACE
Official Title
Electronic Repositioning With Acuity and Easytrak Leads
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 2006 (Actual)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
305 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LV lead electronically repositioning
Arm Type
Other
Arm Description
Single arm study
Intervention Type
Device
Intervention Name(s)
Electronic Repositioning
Intervention Description
Change of pacing vectors for CRT pacing
Primary Outcome Measure Information:
Title
Proportion of Patients Without the Occurrence of Cardiac Resynchronization Therapy (CRT)-Induced Phrenic Nerve Stimulation (PNS) Between Implant and First Regular Follow-up (FU)
Description
The primary endpoint was the percentage of patients in whom PNS induced by Left Ventricular (LV) pacing could be avoided by electronic repositioning from implantation to first regular follow up (3-6 months postimplant). In this evaluation, prevention of PNS was defined as PNS appearing with the standard pacing configuration-LV tip as cathode versus Right Ventricle (RV) coil as anode-and being avoided by at least one of the three alternative reprogrammable configurations.
Time Frame
From implant until first follow up (occurred between 3 or 6 month after implant procedure)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients receiving their FIRST implantation of a Left Ventricular (LV) lead in combination with a CRT device with implantable cardioverter defibrillator (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 Follow up
18 years old
Known pregnancy.
Facility Information:
Facility Name
University Hospital
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Electronic Repositioning With Acuity and Easytrak Leads
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