Real Time 3-Dimensional Echocardiography for Left Ventricular Lead Site Selection to Reduce Cardiac Resynchronization Therapy Non-Responder Rates
NCT ID: NCT01278030
Last Updated: 2019-02-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
78 participants
INTERVENTIONAL
2010-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Control group
Patients will be implanted according to the standard of care with the LV lead in the traditional LV lead position.
No interventions assigned to this group
3D echo-guided LV lead placement group
Information about left ventricular mechanical dyssynchrony and the location of the site of latest mechanical activation based on Real-Time 3-Dimensional Echocardiography (RT3DE) will be available to the physician at the time of implant. This location will be used as the target for optimal LV lead placement.
3D echo-guided LV lead placement
Information about left ventricular mechanical dyssynchrony and the location of the site of latest mechanical activation based on RT3DE will be available to the physician from the core lab analysis. This location will be used as the target for optimal LV lead placement.
Interventions
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3D echo-guided LV lead placement
Information about left ventricular mechanical dyssynchrony and the location of the site of latest mechanical activation based on RT3DE will be available to the physician from the core lab analysis. This location will be used as the target for optimal LV lead placement.
Eligibility Criteria
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Inclusion Criteria
* Patients will have an approved indication per American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines for implantation of a CRT-D
* Patients will receive a new implant or an upgrade from an existing pacemaker or Implantable Cardiovertor Defibrillator with no prior Left Ventricular lead placement
* Patients must be in sinus rhythm at the time of enrollment visit and baseline measurements
Exclusion Criteria
* Heart transplantation
* Recent myocardial infarction (\< 90 days)
* Contra-indication to contrast agent
* Are less than 18 years of age
* Are pregnant
* Are currently participating in a clinical investigation that includes an active treatment arm
* Have a life expectancy of less than 6 months
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Locations
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The Heart Group
Nashville, Tennessee, United States
Countries
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Other Identifiers
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CRD 534
Identifier Type: -
Identifier Source: org_study_id
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