The goal of this observational study is to evaluate the long-term clinical outcomes of physiologic cardiac resynchronization therapy (CRT) using conduction system pacing strategies compared with conventional biventricular CRT in patients with heart failure with reduced ejection fraction (HFrEF) and electrical dyssynchrony.
The main questions it aims to answer are:
* Does physiologic CRT (including left bundle branch area pacing \[LBBAP\] and LBBAP-optimized CRT) reduce the combined risk of all-cause mortality and heart failure hospitalization compared with conventional biventricular CRT? * Does physiologic CRT improve cardiac function and reverse ventricular remodeling more effectively than conventional CRT?
Participants receiving physiologic CRT as part of routine clinical care will undergo standard follow-up evaluations, including electrocardiography, echocardiography, laboratory testing, and device interrogation. Clinical outcomes will be collected prospectively for 24 months and compared with a historical cohort of patients treated with conventional biventricular CRT.
The study will assess clinical outcomes, echocardiographic response, electrical resynchronization parameters, and device-related safety in a real-world heart failure population.
Age ≥18 years.
Symptomatic heart failure despite guideline-directed medical therapy.
Left ventricular ejection fraction (LVEF) ≤40%.
Indication for cardiac resynchronization therapy according to contemporary ESC guideline recommendations.
Age <18 years and Age 100 < years
Pregnancy or breastfeeding.
Inability or unwillingness to provide informed consent.
Life expectancy <12 months due to non-cardiac comorbidities.
The study population consists of adult patients with heart failure with reduced ejection fraction (HFrEF) who are treated at the University of Pécs Clinical Centre Heart Institute and meet contemporary guideline indications for cardiac resynchronization therapy (CRT). Eligible participants have symptomatic heart failure despite guideline-directed medical therapy, left ventricular systolic dysfunction, and evidence of electrical dyssynchrony manifested by left bundle branch block (LBBB) or intraventricular conduction delay (IVCD). The prospective cohort includes patients undergoing conduction system pacing-based CRT as part of routine clinical care, while the historical control cohort includes patients previously treated with conventional biventricular CRT at the same institution. The study population represents a real-world heart failure population routinely referred for CRT implantation in tertiary cardiovascular care.
Cohort
Prospective
Physiologic cardiac resynchronization using conduction system pacing and selective LV lead optimization.
DeviceConduction System Pacing-Guided Cardiac Resynchronization Therapy is an individualized resynchronization strategy used in patients with heart failure, reduced left ventricular ejection fraction, and electrical dyssynchrony. The intervention is based on direct recruitment of the native cardiac conduction system through left bundle branch area pacing (LBBAP). During implantation, electrical resynchronization is assessed using electrocardiographic and device-derived parameters. In patients with intraventricular conduction delay or incomplete electrical correction, additional left ventricular pacing may be provided using a coronary sinus lead, resulting in Left Bundle Branch Area Pacing Optimized Cardiac Resynchronization Therapy (LOT-CRT). The intervention aims to achieve more physiological ventricular activation than conventional biventricular pacing, improve electrical synchrony, promote reverse ventricular remodeling, and reduce heart failure-related adverse events.
Composite of All-Cause Mortality and Heart Failure Hospitalization
Time to first occurrence of the composite endpoint of all-cause mortality or hospitalization due to worsening heart failure during the 24-month follow-up period.
Change in Left Ventricular Ejection Fraction (LVEF)
Change in left ventricular ejection fraction measured by transthoracic echocardiography between baseline and 24-month follow-up. Ejection fraction is measured in percentage (%). Improvement in ejection fraction is detected as increase in percentage-value.
Change in Left Ventricular End-Systolic Volume ( LV ESV)
Change in left ventricular end-systolic volumen measured by echocardiography between baseline and 24-month follow-up. Left ventricular end-systolic volume in measured in mililiters ( ml) , decrease in LV ESV is a sign of clinical response on therapy.
Change in paced QRS Duration
Reduction in QRS duration following cardiac resynchronization therapy compared with baseline electrocardiographic measurements. Paced QRS duration is measured in miliseconds (ms). Decrease in paced QRS duration compared to preoperative QRS duration is marked as a good signal in cardiac resynchronization therapy.
New York Heart Association Heart Failure Functional Status
Change in New York Heart Association (NYHA) functional class from baseline to follow-up. Stage I-IV. NYHA improvement is detected as decrease in NYHA stage grade.
Device-Related and Procedure-Related Complications
Incidence of device-related and procedure-related adverse events, including lead dislodgement, infection, pneumothorax, pocket hematoma, and system revision.
Click on the lead sponsor to view all of their trials.
University of Pecs
Lead sponsor
Medical University of Pecs
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
