Actively Recruiting
Randomized Study Comparing Conventional Biventricular Pacing and Left Bundle Branch Pacing on Heart Function and Clinical Outcomes in Chronic Heart Failure Patients with Reduced Ejection Fraction
Led by Tomsk National Research Medical Center of the Russian Academy of Sciences · Updated on 2025-09-10
60
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Heart failure (HF) is a common and serious condition that increases with age and leads to higher mortality, frequent hospital stays, and reduced quality of life. Cardiac resynchronization therapy (CRT) using biventricular pacing has helped many patients with reduced left ventricular function and left bundle branch block (LBBB), but about 30% do not respond to this treatment. New pacing methods like His bundle pacing (HBP) and left bundle branch pacing (LBBP) have been developed, with LBBP showing promising clinical advantages and potentially better outcomes for patients with chronic HF and reduced ejection fraction. This study compares two types of CRT devices: one using conventional biventricular pacing and the other using left bundle branch pacing. Both therapies involve implanting a cardioverter-defibrillator with pacing leads placed through veins to the heart. The biventricular pacing device stimulates both ventricles, while the LBBP device targets the left bundle branch directly, aiming for improved heart function. The implantation procedure includes local anesthesia, lead placement, and device programming. The study will observe and compare these two approaches to evaluate their effects on heart remodeling and clinical outcomes. Participants will be monitored for 24 months after implantation. Researchers will assess outcomes such as overall mortality, heart failure worsening requiring hospitalization, ventricular function, exercise tolerance, and quality of life using specific questionnaires. Device performance and heart rhythm events will also be tracked. The study includes detailed evaluations with echocardiography, laboratory tests, and biomarker analysis to understand how each therapy influences heart structure and function. Follow-up visits will ensure safety and effectiveness data are collected throughout the study period.
CONDITIONS
Brief Title
Conventional Biventricular Versus Left Bundle Branch Pacing on Outcomes in Heart Failure Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The patient is willing and able to comply with the protocol and has provided written informed consent
- Male or female patients aged 18 to 80 years
- Patients with ischemic or non-ischemic cardiomyopathy
- Symptomatic heart failure for at least 3 months prior to enrollment
- New York Heart Association (NYHA) functional class heart failure II or higher
- Heart failure in sinus rhythm with left ventricular ejection fraction (LVEF) 35% or less, QRS duration 150 ms or more with left bundle branch block (LBBB) morphology
- Heart failure in sinus rhythm with LVEF 35% or less, QRS duration 130-149 ms with LBBB morphology
- Heart failure in sinus rhythm with LVEF 35% or less, QRS duration 150 ms or more with non-LBBB morphology
- Symptomatic persistent or permanent atrial fibrillation with heart failure and LVEF less than 40%, candidates for atrioventricular junction ablation
- Heart failure with LVEF less than 40% and indications for continuous ventricular pacing due to bradycardia
- Patients with conventional pacemaker or implanted cardioverter-defibrillator who develop symptomatic heart failure with LVEF less than 40% despite optimal medical therapy and significant right ventricle pacing
- Receiving optimal heart failure medical therapy
You will not qualify if you...
- Coronary artery bypass grafting, balloon dilatation, or stenting within 3 months prior to enrollment
- Acute myocardial infarction within 3 months prior to enrollment
- Acute coronary syndrome
- Planned cardiovascular intervention such as bypass grafting, balloon dilatation, or stenting
- Listed for heart transplant
- Implanted cardiac assist device
- Acute myocarditis
- Infiltrative myocardial disease
- Hypertrophic cardiomyopathy
- Severe primary stenosis or regurgitation of mitral, tricuspid, or aortic valves
- Women who are pregnant, breastfeeding, or not using reliable contraception during fertility
- Mental or physical inability to participate
- Unwillingness or inability to cooperate with the study protocol
- Rheumatic heart disease
- Mechanical tricuspid valve
- Any serious medical condition interfering with the study
- Enrollment in another investigational drug or device study
- Unavailable for follow-up
- Severe chronic kidney disease with estimated glomerular filtration rate less than 30 ml/min/1.73 m2
- Life expectancy 12 months or less
- Participation in another telemonitoring concept
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive implantation of a cardioverter-defibrillator with a resynchronization function using either biventricular pacing or left bundle branch pacing.
1 implantation visit (in-person)
Duration - Up to 24 months
Participants are treated with cardiac resynchronization therapy through their implanted device to improve heart function and clinical outcomes.
Regular follow-up visits during the treatment period
Trial Site Locations
Total: 1 location
1
Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
Tomsk, Russia
Actively Recruiting
Research Team
T
Tariel A Atabekov, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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