ECG Belt for CRT Response



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:2/8/2019
Start Date:July 13, 2018
End Date:January 2022
Contact:Peter Kratz
Email:peter.r.kratz@medtronic.com
Phone:763-526-2802

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The purpose of this clinical study is to compare ECG Belt Research System managed cardiac
resynchronization therapy (CRT) patients and a control CRT group with respect to left
ventricular (LV) remodeling.

The ECG Belt study is a prospective, interventional, randomized, multi-center,
investigational, pre-market research study. The ECG Belt Research System will be used at
implant and follow-up to help implanters choose a suitable LV pacing site within the
recommended locations for LV lead implantation and optimize pacing vector/timing parameters.

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 LV
lead.

- Meets at least one of the following criteria: QRS duration < 150 ms, Prior documented
Myocardial Infarction, Non-LBBB

- LVEDD ≥ 55 mm, as determined by site

Exclusion Criteria:

- Permanent/persistent AF or presenting with AF

- 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

- Permanent complete AV block

- Enrolled in a concurrent study that may confound the results of this study.
Pre-approval from the study manager is required for enrollment of a patient that is in
a concurrent study.

- Less than 1 year life expectancy

- Vulnerable adults

- Younger than 18 years of age
We found this trial at
11
sites
West Des Moines, Iowa 50266
Principal Investigator: Troy Hounshell, Dr.
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West Des Moines, IA
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Niraj Varma, Dr.
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Principal Investigator: David Frankel, Dr.
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Philadelphia, PA
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Austin, Texas 78758
Principal Investigator: Robert Canby, Dr.
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Austin, TX
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Bologna, 40138
Principal Investigator: Igor Diemberger, Dr.
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Bologna,
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Columbus, Ohio 43213
Principal Investigator: Joshua Silverstein, Dr.
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Columbus, OH
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Kevin Jackson, Dr.
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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Gainesville, Florida
Principal Investigator: Thomas Burkart, Dr.
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Gainesville, FL
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4401 Wornall Rd
Kansas City, Missouri 64111
(816) 932-2000
Principal Investigator: Brian Ramza, Dr.
Saint Luke's Hospital, Kansas City Saint Luke's Hospital is a not-for-profit tertiary referral center committed...
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Kansas City, MO
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Lincoln, Nebraska 68506
Principal Investigator: W.Michael Kutayli, Dr.
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Lincoln, NE
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New Haven, Connecticut 06520
Principal Investigator: Eric Grubman, Dr.
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New Haven, CT
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