An interventional study of Programming of CRT device settings in Heart Failure, Systolic, sponsored by Minneapolis Heart Institute Foundation. Withdrawn at 2 sites in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-03-04.
Sponsored by Minneapolis Heart Institute Foundation · Not applicable, Interventional, and Treatment
Cardiac resynchronization therapy (CRT), or atrial-synchronized biventricular (BiV) pacing, is an FDA-approved device therapy option for heart failure (HF) patients with reduced left ventricular ejection fraction and electrical dyssynchrony. A traditional CRT device has pacing leads implanted within the right atrium (RA), the right ventricle (RV), and within a coronary vein overlying the lateral or posterior left ventricle (LV). Within the past decade, various multi-center randomized controlled trials have reported improved quality of life, aerobic exercise capacity, LV systolic function and structure, as well as decreased hospitalization rates and mortality among patients with HF. Despite improvements in CRT technology with multipoint pacing, quadripolar leads, and adaptive pacing algorithms, approximately 30% of patients do not clinically benefit and are considered non-responders. This study looks to optimize CRT device programming in patients considered non-responders to CRTusing information obtained from standard ECG machines, and to assess acute and chronic effects of CRT optimization using cardiac magnetic resonance imaging (CMR).
This is a prospective, randomized study designed to evaluate if CRT device optimization, guided by electrocardiography, improves cardiac function and clinical outcomes among patients considered non-responders to CRT. All patients will have electrocardiographic assessment of electrical dyssynchrony at a range of device settings using standard ECG machines. All patients will then have a baseline CMR study at baseline CRT programming, underlying rhythm, and optimal settings derived from the electrocardiographic assessment to assess acute effects of CRT optimization on mechanical synchrony, LV regional wall motion, and LV structure/ function. To assess chronic effects of CRT optimization, patients will be randomized in a 1:1 ratio after baseline CMR to either the active comparator arm (baseline CRT programming), or the experimental arm (CRT device programmed to optimal settings derived from the electrocardiographic assessment). Patients will be blinded to randomization. After 6 month, all patients will return for follow up CMR study to assess chronic effects. After follow up CMR imaging, the active comparator group will crossover to the experimental group. After 12 months, all patients will return for follow up echocardiogram to further evaluate the chronic effects of CRT optimization.
227 studies on the registry are indexed under Heart Failure, Systolic; 50 are open to participants now.
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Exclusion Criteria:
The comparator arm patients will remain at baseline CRT programming for the first 6 months, and then will crossover to the experimental arm and CRT device will be programmed to optimal settings derived from the electrocardiographic assessment for the following 6 months.
Device: Programming of CRT device settings
The experimental arm patients will have CRT device programmed based on the electrocardiographic assessment for 12 months.
Device: Programming of CRT device settings
Reprogramming of CRT device to maximize the benefit derived from the electrocardiographic assessment.
Acute changes in left ventricular mechanical synchrony in study population
Acute changes, measured by cardiac magnetic resonance imaging, in left ventricular mechanical synchrony at underlying rhythm, baseline CRT programming, and optimal programming derived from electrocardiographic assessment in all patients.
Time frame: During Baseline Assessment
Acute changes in left ventricular regional wall motion in study population
Acute changes, measured by cardiac magnetic resonance imaging, in left ventricular wall motion at underlying rhythm, baseline CRT programming, and optimal programming derived from electrocardiographic assessment in all patients.
Time frame: During Baseline Assessment
Acute changes in left ventricular end-diastolic volume in study population
Acute changes, measured by cardiac magnetic resonance imaging, in left ventricular end-diastolic volume at underlying rhythm, baseline CRT programming, and optimal programming derived from electrocardiographic assessment in all patients.
Time frame: During Baseline Assessment
Acute changes in left ventricular end-systolic volume in study population
Acute changes, measured by cardiac magnetic resonance imaging, in left ventricular end-systolic volume at underlying rhythm, baseline CRT programming, and optimal programming derived from electrocardiographic assessment in all patients.
Time frame: During Baseline Assessment
Chronic changes in left ventricular mechanical synchrony
Chronic changes, measured by cardiac magnetic resonance imaging and echocardiography, in left ventricular mechanical synchrony between the experimental and active comparator group.
Time frame: Baseline to 12 months
Chronic changes in left ventricular regional wall motion
Chronic changes, measured by cardiac magnetic resonance imaging and echocardiography, in left ventricular regional wall motion between the experimental and active comparator group.
Time frame: Baseline to 12 months
Chronic changes in left ventricular end-diastolic volume
Chronic changes, measured by cardiac magnetic resonance imaging and echocardiography, in left ventricular end-diastolic volume between the experimental and active comparator group.
Time frame: Baseline to 12 months
Chronic changes in left ventricular end-systolic volume
Chronic changes, measured by cardiac magnetic resonance and echocardiographic imaging, in left ventricular end-systolic volume between the experimental and active comparator group.
Time frame: Baseline to 12 months
Change in 6 Minute Hall Walk (6MHW)
Comparison between experimental arm and active comparator arm in 6MHW
Time frame: Baseline to 12 months
Change in Kansis City Cardiomyopathy Questionnaire (KCCQ)
Comparison between experimental arm and active comparator arm in KCCQ. Scores are scaled 0-100. Higher scores indicate better outcomes.
Time frame: Baseline to 12 months
Correlation in electrical dyssynchrony and left ventricular function in study population
Changes in electrical dyssynchrony, measured by electrocardiography, and correlation to change in left ventricular function, measured by cardiac magnetic resonance and echocardiographic imaging, in all patients.
Time frame: Baseline to 12 months
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Plan to share: No — We do not plan to share IPD with other external researchers.
This study is withdrawn, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Minneapolis Heart Institute Foundation