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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - Other serious medical condition with life expectancy of less than 1 year - Lack of capacity to consent - Pregnancy - Previous aortic valve surgery Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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 Exclusion Criteria: * Other serious medical condition with life expectancy of less than 1 year * Lack of capacity to consent * Pregnancy * Previous aortic valve surgery

Treatments Being Tested

DEVICE

High 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.

Locations (1)

Miulli General Hospital
Acquaviva delle Fonti, Bari, Italy