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

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Abbott

Status

Completed

Conditions

Heart Failure

Treatments

Procedure: 3D echo-guided LV lead placement

Study type

Interventional

Funder types

Industry

Identifiers

NCT01278030
CRD 534

Details and patient eligibility

About

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.

Enrollment

78 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

78 participants in 2 patient groups

Control group
No Intervention group
Description:
Patients will be implanted according to the standard of care with the LV lead in the traditional LV lead position.
3D echo-guided LV lead placement group
Experimental group
Description:
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.
Treatment:
Procedure: 3D echo-guided LV lead placement

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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