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ECG Belt for CRT Response

Primary Objective

Demonstrate benefit of using the ECG Belt Research System on reducing left ventricular end-systolic volume (LVESV) from baseline to 6 months post-implant compared to standard CRT. ECG Belt arm subjects will be compared with the control arm subjects (combined control arms A and B). A core lab blinded to randomization and follow up status will analyze the echo data and measure LVESV.

Study category: Heart and Blood Conditions

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Description

Demonstrate benefit of using the ECG Belt Research System on reducing left ventricular end-systolic volume (LVESV) from baseline to 6 months post-implant compared to standard CRT. ECG Belt arm subjects will be compared with the control arm subjects (combined control arms A and B). A core lab blinded to randomization and follow up status will analyze the echo data and measure LVESV.

Details
Age

Adult

Eligibility

Indicated for CRT, with QRS duration &#8805;130 ms, and planned to be implanted with a market-released Medtronic CRT device with AdaptivCRT and a market-released Medtronic quadripolar LV lead. &#8226; Meets at least one of the following criteria: o QRS duration < 150 ms o Prior documented Myocardial Infarction o Non-LBBBa1

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 market-released Medtronic quadripolar LV lead. • Meets at least one of the following criteria: o QRS duration < 150 ms o Prior documented Myocardial Infarction o Non-LBBBa1 • LVEDD ≥ 55 mm, as determined by site Exclusion criteria • Permanent/persistent atrial fibrillation (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 implantable pulse generator (IPG) or implantable cardioverter defibrillator (ICD) with >10% RV pacing • Permanent complete atrioventricular (AV) block • Enrolled in a concurrent study that may confound the results of this study. Preapproval from the study manager is required for enrollment of a patient that is in a concurrent study. • Less than 1 year life expectancy

Type of Study

Outcomes Research

Location

University of Colorado Hospital

Principal Investigator
Ryan Borne,  MD

Ryan Borne, MD

Study ID

Protocol Number: 19-1703

More information available at ClinicalTrials.gov: NCT03504020

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