ECG Belt for CRT Response

Completed · Not applicable

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT03504020

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

498

Starts

2018-07-13

Expected to finish

2022-04-20

Last updated by the study team

2023-02-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hartford Hospital — Hartford, Connecticut, United States
• Yale School of Medicine — New Haven, Connecticut, United States
• MedStar Washington Hospital Center — Washington D.C., 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
• Advanced Cardiovascular Specialists — Shreveport, Louisiana, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Saint Lukes Hospital of Kansas City — Kansas City, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Bryan Heart — Lincoln, Nebraska, United States
• Morristown Memorial Hospital — Morristown, New Jersey, United States
• Atrium Health's Carolina Medical Center — Charlotte, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• North Carolina Heart and Vascular — Raleigh, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Mount Carmel East — Columbus, Ohio, United States
• OhioHealth Research and Innovation Institute (OHRI) — Columbus, Ohio, United States
• Oklahoma Heart Hospital — Oklahoma City, Oklahoma, United States
• Lehigh Valley Hospital- Cedar Crest — Allentown, Pennsylvania, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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