About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Physiologic cardiac resynchronization using conduction system pacing and selective LV lead optimization.
Treatment groups
Sponsors and collaborators
University of Pecs
Lead sponsor
Medical University of Pecs
Collaborator