Heart Failure Clinical Trial

ECG Belt for CRT Response

Summary

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.

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Full Description

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.

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Eligibility Criteria

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

Study is for people with:

Heart Failure

Estimated Enrollment:

498

Study ID:

NCT03504020

Recruitment Status:

Completed

Sponsor:

Medtronic Cardiac Rhythm and Heart Failure

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There are 43 Locations for this study

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Hartford Hospital
Hartford Connecticut, 06102, United States
Yale School of Medicine
New Haven Connecticut, 06510, United States
MedStar Washington Hospital Center
Washington District of Columbia, 20010, United States
University of Florida Health Shands Hospital
Gainesville Florida, 32608, United States
Florida Hospital Cardiovascular Research Institute
Orlando Florida, 32803, United States
BayCare Health System
Tampa Florida, 33614, United States
NorthShore University Health System
Evanston Illinois, 60201, United States
Iowa Heart Center
West Des Moines Iowa, 50266, United States
Heartland Cardiology
Wichita Kansas, 67205, United States
Cardiovascular Institute of the South
Houma Louisiana, 70360, United States
Advanced Cardiovascular Specialists
Shreveport Louisiana, 71105, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Saint Lukes Hospital of Kansas City
Kansas City Missouri, 64111, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Bryan Heart
Lincoln Nebraska, 68506, United States
Morristown Memorial Hospital
Morristown New Jersey, 07960, United States
Atrium Health's Carolina Medical Center
Charlotte North Carolina, 28203, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
North Carolina Heart and Vascular
Raleigh North Carolina, 27607, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
Mount Carmel East
Columbus Ohio, 43213, United States
OhioHealth Research and Innovation Institute (OHRI)
Columbus Ohio, 43214, United States
Oklahoma Heart Hospital
Oklahoma City Oklahoma, 73120, United States
Lehigh Valley Hospital- Cedar Crest
Allentown Pennsylvania, 18103, United States
Hospital of the University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
University of Pittsburgh Medical Center UPMC Presbyterian
Pittsburgh Pennsylvania, 15213, United States
Geisinger Wyoming Valley Medical Center
Wilkes-Barre Pennsylvania, 18711, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States
Wellmont CVA Heart Institute
Kingsport Tennessee, 37660, United States
Vanderbilt University medical Center
Nashville Tennessee, 37232, United States
Texas Cardiac Arrhythmia Research Foundation
Austin Texas, 78705, United States
Texas Health Research & Education Institute
Fort Worth Texas, 76104, United States
The University of Vermont Medical Center
Burlington Vermont, 05401, United States
Aurora St. Lukes
Milwaukee Wisconsin, 53215, United States
Onze-Lieve-Vrouwziekenhuis-campus aalst
Aalst , 9300, Belgium
Cliniques Universitaires Saint-Luc
Brussels , 1200, Belgium
University of Ottawa Heart Institute
Ottawa Ontario, K1Y 4, Canada
Montreal Heart Institute
Montréal Quebec, H1T 1, Canada
Rigshospitalet
Kobenhavn , 2100, Denmark
Policlinico Sant' Orsola - Malpighi
Bologna , 40138, Italy
Istituto Auxologico Italiano - Istituto Scientifico Ospedale San Luca
Milano , 20149, Italy
Maastricht Universitair Medisch Centrum (MUMC)
Maastricht , 6229 , Netherlands
Centre Hospitalier Universitaire Vaudois
Lausanne , 1011, Switzerland

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

498

Study ID:

NCT03504020

Recruitment Status:

Completed

Sponsor:


Medtronic Cardiac Rhythm and Heart Failure

How clear is this clinincal trial information?

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