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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Miulli General Hospital
RECRUITING
Acquaviva Delle Fonti
Contact Information
Primary
Grigorios Katsouras, MD, MSc
g.katsouras@miulli.it
0803054219
Backup
Pietro Guida
p.guida@miulli.it
0803054029
Time Frame
Start Date: 2023-03-29
Estimated Completion Date: 2025-02
Participants
Target number of participants: 34
Treatments
Experimental: High intensity His bundle pacing
After implantation of the device there will be a 1-month run-in period that the device will be programmed to deliver His bundle pacing therapy during this period at 3.5V/1msec.~After one month these patients will continue to receive active pacing treatment with 3.5V/1msec.
Sham_comparator: Back up only ventricular pacing
After implantation of the device there will be a 1-month run-in period that the device will be programmed to deliver His bundle pacing therapy during this period at 2V/1msec.~After one month these patients will receive back up only pacing (pacemaker programmed to VVI 30 bpm or AAI(R)-DDD(R) 50bpm) for 6 months.
Sponsors
Leads: Miulli General Hospital

This content was sourced from clinicaltrials.gov

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