High Intensity His Bundle Pacing in Heart Failure Patients With Narrow QRS Outcome Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorMiulli General Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Aged 18 or above

Ventricular Ejection Fraction (EF) < 50%; BNP needs to be ≥250ng/L or N Terminal-pro BNP≥600ng/L for patients with EF 36-50% and they should have an ICD indication

New York Heart Association (NYHA) class I-IV

Narrow QRS duration (≤110ms) on 12 lead ECG

Disqualifiers

Other serious medical condition with life expectancy of less than 1 year

Lack of capacity to consent

Pregnancy

Previous aortic valve surgery

Trial design

Treatments tested in this trial

  • High Intensity His Bundle pacing

Treatment groups

34 Participants
are divided into 2 treatment groups

Sponsors and collaborators