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

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

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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