ECG Belt for CRT Response

Not Applicable

Completed

Conditions: Heart Failure

Interventions: Device: ECG Belt Research System

Registration Number: NCT03504020

Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Brief 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.

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 498

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ECG Belt	ECG Belt Research System	The ECG Belt arm will utilize the ECG Belt Research System at implant and all follow up visits.

Primary Outcome Measures

Name	Time	Method
Change in Left Ventricular End Systolic Volume (LVESV) From Baseline to 6 Months Post-implant.	baseline to 6 months	Relative (%) change in LVESV from the baseline measurement to the 6 month measurement.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (43): MedStar Washington Hospital Center
🇺🇸
Washington, District of Columbia, United States
Advanced Cardiovascular Specialists
🇺🇸
Shreveport, Louisiana, United States
Morristown Memorial Hospital
🇺🇸
Morristown, New Jersey, United States
Wellmont CVA Heart Institute
🇺🇸
Kingsport, Tennessee, United States
Policlinico Sant' Orsola - Malpighi
🇮🇹
Bologna, Italy
Maastricht Universitair Medisch Centrum (MUMC)
🇳🇱
Maastricht, Netherlands
The University of Vermont Medical Center
🇺🇸
Burlington, Vermont, United States
Cliniques Universitaires Saint-Luc
🇧🇪
Brussels, Belgium
Montreal Heart Institute
🇨🇦
Montréal, Quebec, Canada
Hospital of the University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
Cleveland Clinic
🇺🇸
Cleveland, Ohio, United States
OhioHealth Research and Innovation Institute (OHRI)
🇺🇸
Columbus, Ohio, United States
Washington University School of Medicine
🇺🇸
Saint Louis, Missouri, United States
Atrium Health's Carolina Medical Center
🇺🇸
Charlotte, North Carolina, United States
Geisinger Wyoming Valley Medical Center
🇺🇸
Wilkes-Barre, Pennsylvania, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
Rigshospitalet
🇩🇰
Kobenhavn, Denmark
Hartford Hospital
🇺🇸
Hartford, Connecticut, United States
Mount Carmel East
🇺🇸
Columbus, Ohio, United States
North Carolina Heart and Vascular
🇺🇸
Raleigh, North Carolina, United States
Cardiovascular Institute of the South
🇺🇸
Houma, Louisiana, United States
Istituto Auxologico Italiano - Istituto Scientifico Ospedale San Luca
🇮🇹
Milano, Italy
Centre Hospitalier Universitaire Vaudois
🇨🇭
Lausanne, Switzerland
BayCare Health System
🇺🇸
Tampa, Florida, United States
Mayo Clinic
🇺🇸
Rochester, Minnesota, United States
Oklahoma Heart Hospital
🇺🇸
Oklahoma City, Oklahoma, United States
Aurora St. Lukes
🇺🇸
Milwaukee, Wisconsin, United States
Vanderbilt University medical Center
🇺🇸
Nashville, Tennessee, United States
NorthShore University Health System
🇺🇸
Evanston, Illinois, United States
Iowa Heart Center
🇺🇸
West Des Moines, Iowa, United States
Bryan Heart
🇺🇸
Lincoln, Nebraska, United States
Heartland Cardiology
🇺🇸
Wichita, Kansas, United States
Lehigh Valley Hospital- Cedar Crest
🇺🇸
Allentown, Pennsylvania, United States
Onze-Lieve-Vrouwziekenhuis-campus aalst
🇧🇪
Aalst, Belgium
Texas Health Research & Education Institute
🇺🇸
Fort Worth, Texas, United States
University of Pittsburgh Medical Center UPMC Presbyterian
🇺🇸
Pittsburgh, Pennsylvania, United States
University of Ottawa Heart Institute
🇨🇦
Ottawa, Ontario, Canada
Florida Hospital Cardiovascular Research Institute
🇺🇸
Orlando, Florida, United States
Yale School of Medicine
🇺🇸
New Haven, Connecticut, United States
Saint Lukes Hospital of Kansas City
🇺🇸
Kansas City, Missouri, United States
Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States
Texas Cardiac Arrhythmia Research Foundation
🇺🇸
Austin, Texas, United States
University of Florida Health Shands Hospital
🇺🇸
Gainesville, Florida, United States