Actively Recruiting
High Intensity His Bundle Pacing in Heart Failure Patients With Narrow QRS Outcome Study
Led by Miulli General Hospital · Updated on 2025-12-22
34
Participants Needed
1
Research Sites
161 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
High Intensity His Bundle Pacing in Heart Failure Patients With Narrow QRS Outcome Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Ventricular Ejection Fraction less than 50%
- BNP of 250 ng/L or higher, or N Terminal-pro BNP of 600 ng/L or higher for patients with EF 36-50%
- Indication for implantable cardioverter defibrillator (ICD)
- New York Heart Association (NYHA) class I to IV
- Narrow QRS duration (110 milliseconds or less) on 12-lead ECG
You will not qualify if you...
- Serious medical condition with life expectancy less than 1 year
- Unable to give informed consent
- Pregnant
- Previous aortic valve surgery
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Miulli General Hospital
Acquaviva delle Fonti, Bari, Italy, 70021
Actively Recruiting
Research Team
G
Grigorios Katsouras, MD, MSc
CONTACT
P
Pietro Guida
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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