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ECG BELT
FOR CRT RESPONSE STUDY
Steering Committee:
Alan Bank, MD, United Heart and Vascular Clinic, St. Paul, MN, USA
John Rickard, MD, Cleveland Clinic, Cleveland, OH, USA
Mauro Biffi, MD, University of Bologna, Bologna, Italy
INTRODUCTION
DESIGN
OBJECTIVES
Following CRT implant, approximately 20-25% of heart failure patients do not
appear to improve. A key unmet need is a means to determine acute response to
CRT pacing during implant and follow-up procedures. Such feedback may
improve LV lead placement and programming, thus improving patient outcomes.
 Prospective, randomized 2:1:1 (ECG Belt, Control A, Control B), pre-market
 400 randomized subjects
 48 sites in US, Canada, and Europe
Primary Objective:
Demonstrate benefit of using the ECG Belt System on reducing LVESV from
baseline to 6 months post-implant
The primary purpose of this study is to evaluate the ECG Belt System as an
additional diagnostic tool for optimizing CRT therapy by comparing left
ventricular remodeling in ECG Belt managed CRT patients and a control CRT
group.
ECG Belt arm
(n=200)
Implant
ECG Belt: LV lead
pacing site
Post-implant
ECG Belt:
Programming
management
BACKGROUND
The ECG Belt System employs multiple rows of electrodes applied to the anterior
as well as posterior portions of the torso. The belt provides isochronal maps of
electrical activation and metrics of electrical heterogeneity. These maps and
metrics are computed during intrinsic rhythm as well as during pacing to
determine the changes from intrinsic to pacing rhythm.
6-9 months
Control arms
(n=200)
Routine Implant
ECG Belt: Blinded data collection
Further ECG Belt research testing
Ancillary Objectives:
 Estimate the benefit of using the ECG Belt System on LVEF
 Estimate the benefit of using the ECG Belt System on change in quality of life
 Estimate the benefit of using the ECG Belt system on the Clinical Composite
Score
 Characterize ECG Belt system related adverse events
 Assess the changes in LVESV from 6-9 months between subjects who have
and have not used the ECG Belt at 6 months
 Assess the extent of ECG Belt guided programming changes across study
visits
STATUS
Study Status: Site activation
Estimated Study Start Date: November 2016
Estimated Study Completion Date: September 2019
ECG Belt Research System
PATIENT CRITERIA
Intrinsic (CRT OFF)
SDAT = 40 ms
QRS duration =
175 ms
CRT Pacing ON
SDAT = 17 ms
0 ms
Activation time
120 ms
In a CRT super-responder
(∆LVESV = -31%), the change
is SDAT better reflected CRT
response QRS duration.*
QRS duration =
170 ms
Improved Global Heterogeneity (SDAT) with CRT
Pacing OFF → ON predicts LVESV remodeling (n=58)
Changes in ECG Belt metrics
(CRT pacing OFF → ON) made
greater differences in LV endsystolic volume changes in CRT
patients compared to 12-lead
ECG metrics of QRS duration or
morphology.*
*Reference: Gage R, Curtin AE, Burns KV, Gillberg J, Ghosh S, Bank AJ. Changes in electrical heterogeneity by body surface mapping predict
LV remodeling in CRT patients. Heart Rhythm Society Annual meeting, San Francisco, CA, 2016.
Inclusion Criteria:
 Indicated for CRT, with QRS duration >130 ms, and planned to be implanted
with a market-released Medtronic CRT device with AdaptivCRT and a
Medtronic quadripolar lead
 Meets at least one of the following criteria
 QRS duration < 150 ms
 Prior documented Myocardial Infarction
 Non-LBBB
Exclusion Criteria:
 Permanent/persistent AF or presenting with AF with ventricular rate ≥ 90 BPM
 Pre-existing or previous LV lead or other confounding devices e.g. Left
Ventricular Assist Device, Vagal Nerve Stimulator
 Currently implanted with IPG or ICD with > 10% RV pacing
 Complete AV block
 Enrolled in a concurrent study that may confound the results of this study
 Less than 1 year life expectancy
 Younger than 18 years of age
CONTACTS
Clinical Study Team:
 Mireille van Ginneken, Global Study Leader
[email protected]
 Katie Weiner, US Study Manager
[email protected]
ECG Belt Concept/Prior Research:
 Subham Ghosh, Principal Scientist
[email protected]
 Jeff Gillberg, HF Research Director, Bakken Fellow
[email protected]
Sponsor: Medtronic, Inc.
Funding: Medtronic, Inc.
ClinicalTrials.gov: TBD