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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

Detailed 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 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

Phase

Not Applicable - Describes studies without FDA-defined phases, including studies of devices or behavioral interventions.

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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