TY - JOUR
T1 - The ECG Belt for CRT response trial
T2 - Design and clinical protocol
AU - Rickard, John
AU - Jackson, Kevin
AU - Biffi, Mauro
AU - Vernooy, Kevin
AU - Bank, Alan
AU - Cerkvenik, Jeff
AU - Ghosh, Subham
AU - Gold, Michael R.
N1 - Funding Information:
The ECG Belt for CRT response study (ClinicalTrials.gov ID: NCT03504020) is funded by Medtronic, plc.
Publisher Copyright:
© 2020 Wiley Periodicals LLC
PY - 2020/10
Y1 - 2020/10
N2 - The ECG Belt for CRT response trial is designed to test the hypothesis that in patients traditionally less likely to respond to cardiac resynchronization therapy (CRT), an individualized approach utilizing the electrocardiogram (ECG) Belt to guide lead placement, vector selection, and device programming is superior to current standard of care. The ECG Belt is a noninvasive mapping technology designed to measure beat by beat electrical activation of the left ventricle by utilizing unipolar measurements from multiple ECG electrodes on the body surface. The ECG Belt for CRT response trial is a multicenter, prospective, randomized, investigational pre-market research study conducted at 48 centers in the United States, Canada, and Europe and will randomize approximately 400 subjects. The trial has three arms (enrollment will be 2:1:1, respectively): utilization of the Belt to guide implant as well as postimplant programming, utilizing the Belt to guide postimplant programming alone, and a non-Belt control arm. AdaptivCRT will be an option in the treatment arm but not the control arms. The primary endpoint is change in left ventricular end-systolic volume between preimplant and at 6 months. This paper describes the design and analytic plan for the trial.
AB - The ECG Belt for CRT response trial is designed to test the hypothesis that in patients traditionally less likely to respond to cardiac resynchronization therapy (CRT), an individualized approach utilizing the electrocardiogram (ECG) Belt to guide lead placement, vector selection, and device programming is superior to current standard of care. The ECG Belt is a noninvasive mapping technology designed to measure beat by beat electrical activation of the left ventricle by utilizing unipolar measurements from multiple ECG electrodes on the body surface. The ECG Belt for CRT response trial is a multicenter, prospective, randomized, investigational pre-market research study conducted at 48 centers in the United States, Canada, and Europe and will randomize approximately 400 subjects. The trial has three arms (enrollment will be 2:1:1, respectively): utilization of the Belt to guide implant as well as postimplant programming, utilizing the Belt to guide postimplant programming alone, and a non-Belt control arm. AdaptivCRT will be an option in the treatment arm but not the control arms. The primary endpoint is change in left ventricular end-systolic volume between preimplant and at 6 months. This paper describes the design and analytic plan for the trial.
KW - cardiac resynchronization therapy
KW - electrocardiographic imaging
KW - CARDIAC-RESYNCHRONIZATION THERAPY
KW - VENTRICULAR LEAD PLACEMENT
KW - HEART-FAILURE PATIENTS
KW - BUNDLE-BRANCH BLOCK
KW - OPTIMIZATION
KW - ACTIVATION
U2 - 10.1111/pace.13985
DO - 10.1111/pace.13985
M3 - Article
C2 - 32537740
SN - 0147-8389
VL - 43
SP - 1063
EP - 1071
JO - Pacing and Clinical Electrophysiology
JF - Pacing and Clinical Electrophysiology
IS - 10
ER -