ECG Belt for CRT Response

Not Applicable

Completed

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

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

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

Locations (43): Hartford Hospital
🇺🇸
Hartford, Connecticut, United States
Yale School of Medicine
🇺🇸
New Haven, Connecticut, United States
MedStar Washington Hospital Center
🇺🇸
Washington, 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
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Hartford Hospital
🇺🇸Hartford, Connecticut, United States