High Intensity His Bundle Pacing in Heart Failure Patients With Narrow QRS Outcome Study
Recruiting · NCT05491655 · Interventional (participants receive a specific treatment) · Lead sponsor: Miulli General Hospital
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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
Where it is running
1 location listed.
- Miulli General Hospital - Acquaviva delle Fonti, Bari, Italy