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

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Procedure: 3D echo-guided LV lead placement

• Registration Number: NCT01278030
• Lead Sponsor: Abbott Medical Devices

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2011-01-12
• Study First Submitted QC: 2011-01-13
• Study First Posted: 2011-01-17
• Primary Completion: 2012-06
• Results First Submitted: 2013-06-04
• Results First Submitted QC: 2013-10-21
• Results First Posted: 2013-12-09
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3D echo-guided LV lead placement group	3D echo-guided LV lead placement	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.

Primary Outcome Measures

Name	Time	Method
Responder Rate	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.

Trial Locations

Locations (1)

The Heart Group; 🇺🇸 Nashville, Tennessee, United States