Actively Recruiting
Conventional Biventricular Versus Left Bundle Branch Pacing on Outcomes in Heart Failure Patients
Led by Tomsk National Research Medical Center of the Russian Academy of Sciences · Updated on 2025-09-10
60
Participants Needed
1
Research Sites
256 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Heart failure (HF) is the most common nosology encountered in clinical practice. Its incidence and prevalence increase exponentially with increasing age and it is associated with increased mortality, more frequent hospitalization and decreased quality of life. An initial approach to the treatment of HF patients with reduced left ventricular (LV) systolic function and left bundle branch block (LBBB) was implantation of cardioresynchronization device using biventricular pacing. This has resulted in long-term clinical benefits such as improved quality of life, increased functional capacity, reduced HF hospitalizations and overall mortality. However, conventional cardiac resynchronization therapy (CRT) is effective in only 70% of patients. And the remaining 30% of patients are non-responders to conventional CRT. Subsequently, His bundle pacing (HBP) has been developed to achieve the same results. According to other studies HBP has showed greater improvement in hemodynamic parameters than with conventional biventricular CRT. But, nevertheless, there are significant clinical troubles with HBP. In this regard, in 2017, the left bundle branch pacing (LBBP) was developed, which demonstrated clinical advantages compared to biventricular CRT. This method has become an alternative to HBP due to the stimulation of LBB outside the blocking site, a stable pacing threshold and a narrow QRS duration. A series of case reports and observational studies have demonstrated the efficacy and safety of LBBP in patients with CRT indications. However, it is not enough data about CRT with LBBP effectiveness in LV remodeling, reducing mortality and complications. According to our hypothesis, CRT with LBBP compared with conventional biventricular CRT will significantly improve the clinical outcomes and reverse LV remodeling in patients with chronic HF with reduced LV ejection fraction and reduce the number of non-responders to conventional CRT.
CONDITIONS
Official Title
Conventional Biventricular Versus Left Bundle Branch Pacing on Outcomes in Heart Failure Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 functional class II or higher heart failure
- Patients with heart failure in sinus rhythm with left ventricular ejection fraction 35% or less and QRS duration 150 ms or more with left bundle branch block morphology
- Patients with heart failure in sinus rhythm with left ventricular ejection fraction 35% or less and QRS duration 130-149 ms with left bundle branch block morphology
- Patients with heart failure in sinus rhythm with left ventricular ejection fraction 35% or less and QRS duration 150 ms or more with non-left bundle branch block morphology
- Patients with symptomatic persistent or permanent atrial fibrillation, heart failure with left ventricular ejection fraction less than 40%, and uncontrolled heart rate who are candidates for atrioventricular junction ablation
- Patients with heart failure, left ventricular ejection fraction less than 40%, and indications for continuous ventricular pacing due to bradycardia
- Patients with a conventional pacemaker or implanted cardioverter-defibrillator who develop symptomatic heart failure with left ventricular ejection fraction less than 40% despite optimal medical therapy, and have significant right ventricle pacing
- Patients receiving optimal heart failure medical therapy
You will not qualify if you...
- Coronary artery bypass grafting, balloon dilatation, or coronary artery stenting within 3 months prior to enrollment
- Acute myocardial infarction within 3 months prior to enrollment
- Acute coronary syndrome
- Planned cardiovascular interventions such as coronary artery bypass grafting, balloon dilatation, or coronary artery stenting
- Listed for heart transplant
- Implanted cardiac assist device
- Acute myocarditis
- Infiltrative myocardial disease
- Hypertrophic cardiomyopathy
- Severe primary stenosis or regurgitation of the mitral, tricuspid, or aortic valves
- Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertility age
- Mental or physical inability to participate in the study
- Unable or unwilling to cooperate within the study protocol
- Rheumatic heart disease
- Mechanical tricuspid valve
- Any serious medical condition that could interfere with the study
- Enrollment in another investigational drug or device study
- Not available for follow-up
- Severe chronic kidney disease with estimated glomerular filtration rate 30 ml/min/1.73 m2 or less
- Life expectancy 12 months or less
- Participation in another telemonitoring concept
AI-Screening
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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.
CONTACT
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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