Study Results
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View full resultsBasic Information
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COMPLETED
NA
498 participants
INTERVENTIONAL
2018-07-13
2022-04-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ECG Belt
The ECG Belt arm will utilize the ECG Belt Research System at implant and all follow up visits.
ECG Belt Research System
The ECG Belt Research System is used to identify the best vector and programming parameters.
Control Arm
Standard CRT through 6 months follow-up.
No interventions assigned to this group
Interventions
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ECG Belt Research System
The ECG Belt Research System is used to identify the best vector and programming parameters.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Principal Investigators
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ECG Belt for CRT Response Clinical Research Specialist
Role: STUDY_CHAIR
Medtronic
Locations
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Hartford Hospital
Hartford, Connecticut, United States
Yale School of Medicine
New Haven, Connecticut, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
University of Florida Health Shands Hospital
Gainesville, Florida, United States
Florida Hospital Cardiovascular Research Institute
Orlando, Florida, United States
BayCare Health System
Tampa, Florida, United States
NorthShore University Health System
Evanston, Illinois, United States
Iowa Heart Center
West Des Moines, Iowa, United States
Heartland Cardiology
Wichita, Kansas, United States
Cardiovascular Institute of the South
Houma, Louisiana, United States
Advanced Cardiovascular Specialists
Shreveport, Louisiana, United States
Mayo Clinic
Rochester, Minnesota, United States
Saint Lukes Hospital of Kansas City
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Bryan Heart
Lincoln, Nebraska, United States
Morristown Memorial Hospital
Morristown, New Jersey, United States
Atrium Health's Carolina Medical Center
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
North Carolina Heart and Vascular
Raleigh, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Mount Carmel East
Columbus, Ohio, United States
OhioHealth Research and Innovation Institute (OHRI)
Columbus, Ohio, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States
Lehigh Valley Hospital- Cedar Crest
Allentown, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center UPMC Presbyterian
Pittsburgh, Pennsylvania, United States
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Wellmont CVA Heart Institute
Kingsport, Tennessee, United States
Vanderbilt University medical Center
Nashville, Tennessee, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States
Texas Health Research & Education Institute
Fort Worth, Texas, United States
The University of Vermont Medical Center
Burlington, Vermont, United States
Aurora St. Lukes
Milwaukee, Wisconsin, United States
Onze-Lieve-Vrouwziekenhuis-campus aalst
Aalst, , Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Rigshospitalet
Copenhagen, , Denmark
Policlinico Sant' Orsola - Malpighi
Bologna, , Italy
Istituto Auxologico Italiano - Istituto Scientifico Ospedale San Luca
Milan, , Italy
Maastricht Universitair Medisch Centrum (MUMC)
Maastricht, , Netherlands
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Countries
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References
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Rickard J, Jackson K, Biffi M, Vernooy K, Bank A, Cerkvenik J, Ghosh S, Gold MR. The ECG Belt for CRT response trial: Design and clinical protocol. Pacing Clin Electrophysiol. 2020 Oct;43(10):1063-1071. doi: 10.1111/pace.13985. Epub 2020 Sep 1.
Rickard J, Jackson K, Gold M, Biffi M, Ziacchi M, Silverstein J, Ramza B, Metzl M, Grubman E, Abben R, Varma N, Tabbal G, Jensen C, Wouters G, Ghosh S, Vernooy K; ECG Belt for CRT Response Study Group. Electrocardiogram Belt guidance for left ventricular lead placement and biventricular pacing optimization. Heart Rhythm. 2023 Apr;20(4):537-544. doi: 10.1016/j.hrthm.2022.11.015. Epub 2022 Nov 25.
Provided Documents
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Document Type: Study Protocol and Informed Consent Form
Document Type: Statistical Analysis Plan
Other Identifiers
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ECG Belt for CRT Response
Identifier Type: -
Identifier Source: org_study_id
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