RecruitingNot ApplicableNCT05491655

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

Sponsor

Miulli General Hospital

Enrollment

34 participants

Start Date

Mar 29, 2023

Study Type

INTERVENTIONAL

Conditions

Heart Failure Cardiomyopathies Cardiac Conduction System His Bundle Pacing

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.

Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a specialized heart pacing technique called high-intensity His bundle pacing in patients with heart failure whose hearts beat with a normal, narrow rhythm. His bundle pacing aims to restore the heart's natural electrical system to improve pumping. The goal is to see if this approach leads to better outcomes than other forms of pacing in heart failure. **You may be eligible if...** - You are 18 or older - You have heart failure with a weakened pumping function (ejection fraction below 50%) - You have a narrow QRS on your ECG (your heart's electrical signal is not delayed) - You are in New York Heart Association (NYHA) functional class I–IV (mild to very limited activity) - If your pumping function is between 36–50%, you must also have elevated heart failure markers in your blood and need a defibrillator **You may NOT be eligible if...** - You have another serious condition with a life expectancy of less than 1 year - You are unable to give informed consent - You are pregnant - You have previously had aortic valve surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEHigh Intensity His Bundle pacing

All patients will be implanted with an Implantable cardioverter defibrillator (ICD) and an ICD lead in the right ventricle (either RV apex or RV septum). In all patients a pacing lead will be positioned in the right atrium (typically the right atrial appendage). All patients will have a pacemaker lead positioned on the His bundle to obtain direct His-bundle capture.