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

NCT01278030 | Completed Results

• 1 other identifier: CRD 534
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Responder Rate

  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.

  At 6 month follow-up

Study Arms (2)

Control group

NO INTERVENTION

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

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.

Procedure: 3D echo-guided LV lead placement

Interventions

3D echo-guided LV lead placement PROCEDURE

Information about left ventricular mechanical dyssynchrony and the location of the site of latest mechanical activation based on RT3DE will be available to the physician from the core lab analysis. This location will be used as the target for optimal LV lead placement.

3D echo-guided LV lead placement group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

The Heart Group

Nashville, Tennessee, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: John Gill
• Organization: St. Jude Medical

jgill@sjm.com

818-493-2609

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2011
• First Posted: January 17, 2011
• Study Start: August 1, 2010
• Primary Completion: June 1, 2012
• Last Updated: February 19, 2019
• Results First Posted: December 9, 2013

Record last verified: 2019-02

Locations

US (1)