ECG Belt for CRT Response
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.
This Study is
No Longer Enrolling
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.
MoreAdult
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
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
Outcomes Research
University of Colorado Hospital
Protocol Number: 19-1703
More information available at ClinicalTrials.gov: NCT03504020
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