An interventional study of Optimization of CRT Device in Heart Failure, Systolic, sponsored by Alan J. Bank, MD. Completed at 1 site in United States. Open to participants aged 18 Years to 110 Years. Per ClinicalTrials.gov, last updated 2021-09-27.
Sponsored by Alan J. Bank, MD · Not applicable, Interventional, and Treatment
Cardiac resynchronization therapy (CRT) has been a valuable intervention for patients with systolic heart failure for over 15 years. Despite years of research, there is a still a 25-40% non-responder rate depending on the outcomes measured. CRT optimization is a term used to describe the act of individualizing the therapy (CRT programming) for an individual patient. This is not often performed, but when it is, echocardiography is utilized. Recent work of body surface mapping using a novel system called the ECG Belt has shown a relationship between measures of electrical dyssynchrony and acute and chronic heart pumping function. This study will compare outcomes of patients randomized to either echocardiographic or ECG Belt optimization of CRT devices.
This is a prospective randomized study designed to determine whether cardiac resynchronization therapy (CRT) device programming guided by the ECG Belt (Medtronic, PLC) improves echocardiographic and functional outcomes in heart failure (HF) patients. The population will include patients treated with CRT for standard indications (not implanted for the sole purposes of this study). The study will focus enrollment on patients who do not have baseline characteristics predicting the best CRT response. Therefore the study will not enroll patients having non-ischemic HF etiology, left bundle branch (LBBB) morphology, and QRSd > 150 ms or those previously RV paced.
Exclusion Criteria:
Use ECG Belt body surface mapping system to optimize CRT programming.
Diagnostic Test: Optimization of CRT Device
Use mitral inflow echocardiography to optimize CRT programming.
Diagnostic Test: Optimization of CRT Device
Use a body surface mapping system to quantify electrical dyssynchrony or echocardiography to quantify diastolic blood flow characteristics. Program the pacemaker to maximize the benefit of the modality the subject is randomized to.
Echocardiographic assessment of LV function
Change in ejection fraction
Time frame: 6 months post optimization
Echocardiographic assessment of LV size
Change in left ventricular end-systolic volume
Time frame: 6 months post optimization
Plan to share: No — We do not plan to share IPD with other researchers.
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This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Alan J. Bank, MD