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.

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