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

Abbott Medical Devices1 site in 1 country78 target enrollmentAugust 2010

ConditionsHeart Failure

Overview

Phase: N/A
Intervention: Not specified
Conditions: Heart Failure
Sponsor: Abbott Medical Devices
Enrollment: 78
Locations: 1
Primary Endpoint: Responder Rate
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 2010

End Date

June 2012

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abbott Medical Devices

Responsible Party

Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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.