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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:
ClinicalTrials.gov Identifier:
NCT01278030
First Posted: January 17, 2011
Last Update Posted: December 9, 2013
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):
St. Jude Medical
  Purpose
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.

Condition Intervention
Heart Failure Procedure: 3D echo-guided LV lead placement

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Real Time 3-Dimensional Echocardiography for Left Ventricular Lead Site Selection to Reduce Cardiac Resynchronization Therapy Non-Responder Rates (ENVISION)

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Responder Rate [ Time Frame: At 6 month follow-up ]
    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.


Enrollment: 78
Study Start Date: August 2010
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  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): NCT01278030


Locations
United States, Tennessee
The Heart Group
Nashville, Tennessee, United States
Sponsors and Collaborators
St. Jude Medical
  More Information

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01278030     History of Changes
Other Study ID Numbers: CRD 534
First Submitted: January 12, 2011
First Posted: January 17, 2011
Results First Submitted: June 4, 2013
Results First Posted: December 9, 2013
Last Update Posted: December 9, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases