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

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

Inclusion Criteria4

  • 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 Criteria4

  • Other serious medical condition with life expectancy of less than 1 year
  • Lack of capacity to consent
  • Pregnancy
  • Previous aortic valve surgery

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.


Locations(1)

Miulli General Hospital

Acquaviva delle Fonti, Bari, Italy

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NCT05491655


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