Real Time 3-Dimensional Echocardiography for Left Ventricular Lead Site Selection to Reduce Cardiac Resynchronization Therapy Non-Responder Rates (ENVISION)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01278030
First received: January 12, 2011
Last updated: October 21, 2013
Last verified: October 2013

January 12, 2011
October 21, 2013
August 2010
June 2012   (final data collection date for primary outcome measure)
Responder Rate [ Time Frame: At 6 month follow-up ] [ Designated as safety issue: No ]
The responder rate is defined as the proportion of patients with reduction in end systolic volume greater than or equal to 15%. The primary endpoint is the responder rate.
CRT-D responder rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
CRT-D response will be defined as a reduction in LV end systolic volume ≥ 15% after 6 months of CRT.
Complete list of historical versions of study NCT01278030 on ClinicalTrials.gov Archive Site
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Real Time 3-Dimensional Echocardiography for Left Ventricular Lead Site Selection to Reduce Cardiac Resynchronization Therapy Non-Responder Rates
Real Time 3-Dimensional Echocardiography for Left Ventricular Lead Site Selection to Reduce Cardiac Resynchronization Therapy Non-Responder Rates (ENVISION)

The purpose of this study is to demonstrate that cardiac resynchronization therapy (CRT) responder rate can be improved by 3-dimensional (3D) echo-guided left ventricular (LV) lead placement compared to traditional LV lead placement.

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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Heart Failure
Procedure: 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.
  • No Intervention: Control group
    Patients will be implanted according to the standard of care with the LV lead in the traditional LV lead position.
  • Experimental: 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.
    Intervention: Procedure: 3D echo-guided LV lead placement
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
78
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June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients will be implanted with an FDA approved St. Jude Medical CRT-D device (i.e. PROMOTE® or newer devices with similar functionality)
  • 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:

  • Persistent or permanent atrial fibrillation
  • 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
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01278030
CRD 534
No
St. Jude Medical
St. Jude Medical
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St. Jude Medical
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP