High Intensity His Bundle Pacing in Heart Failure Patients With Narrow QRS Outcome Study
Recruiting now · Not applicable
Conditions studied: Cardiac Conduction System, His Bundle Pacing, Heart Failure, Cardiomyopathies
In brief
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.
Key facts
- Study ID
- NCT05491655
- Run by
- Miulli General Hospital
- People needed
- 34
- Starts
- 2023-03-29
- Expected to finish
- 2026-05-01
- Last updated by the study team
- 2025-12-22
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Miulli General Hospital — Acquaviva delle Fonti, Bari, Italy (enrolling)
Full record on ClinicalTrials.gov
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