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Life sciences · Interventional Study
ClinicalTrials.gov · October 16, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT05491655). This is a study registration, not published results. Lead sponsor: Miulli General Hospital. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 40 participants (ACTUAL). Conditions: Cardiac Conduction System, His Bundle Pacing, Heart Failure, Cardiomyopathies. Interventions: DEVICE: High Intensity His Bundle pacing. Primary outcome measures: Change in left ventricular ejection fraction , Baseline pre-intervention, randomisation and 6 months post randomisation. Brief summary: Cardiac Resynchronization Therapy (CRT) decreases heart failure hospitalizations and mortality and increases left ventricular Ejection Fraction (EF) in patients with dilated cardiomyopathy, left bundle branch block and QRS duration \>130msec. His bundle pacing has a similar effect in this category of patients. However, CRT is not beneficial in heart failure (HF) patients with narrow QRS. His-bundle pacing delivers physiological ventricular activation and has been shown to improve acute hemodynamic function in patients with heart failure, a prolonged PR interval, and either a narrow QRS or RBBB through AV delay optimization. We observed an acute hemodynamic effect during application of higher pacing output (3.5 Volts/1 msec) in HF patients with dilated or ischemic cardiomyopathy and narrow QRS independently of the paced QRS duration or AV delay shortening. This is a single-center, prospective randomized single-blinded study, recruiting a sub-population of patients with heart failure (dilated or ischemic cardiomyopathy, EF\<50%, narrow QRS (\<110 msec), in optimal medical treatment who have an indication for ICD.