Conventional Biventricular Versus Left Bundle Branch Pacing on Outcomes in Heart Failure Patients
Recruiting · NCT05769036 · Interventional (participants receive a specific treatment) · Lead sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- 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 HF for at least 3 months prior to enrollment in the study;
- New York Heart Association (NYHA) functional class HF ≥ II;
- Patients with HF in sinus rhythm (SR) with LVEF ≤ 35% (measured in the last 6 weeks prior to enrollment), QRS duration ≥150 ms with LBBB morphology;
- Patients with HF in SR with LVEF ≤ 35% (measured in the last 6 weeks prior to enrollment), QRS duration 130-149 ms with LBBB morphology;
- Patients with HF in SR with LVEF ≤ 35% (measured in the last 6 weeks prior to enrollment), QRS duration ≥150 ms with non-LBBB morphology;
- Patients with symptomatic persistent or permanent atrial fibrillation, HF with LVEF \< 40% (measured in the last 6 weeks prior to enrollment) and an uncontrolled heart rate who are candidates for atrioventricular junction ablation (irrespective of QRS duration);
- Patients with HF, LVEF \< 40% (measured in the last 6 weeks prior to enrollment) and indications for continuous ventricular pacing due to bradycardia;
- Patients who have received a conventional pacemaker or an implanted cardioverter-defibrillator and who subsequently develop symptomatic HF with LVEF \< 40% (measured in the last 6 weeks prior to enrollment) despite optimal medical therapy, and who have a significant proportion of right ventricle pacing;
- Optimal HF medical therapy.
Exclusion criteria
- Coronary artery (CA) bypass grafting, balloon dilatation or CA stenting within 3 months prior to enrollment;
- Acute myocardial infarction within 3 months prior to enrollment;
- Acute coronary syndrome;
- Patients with planned cardiovascular intervention (CA bypass grafting, balloon dilatation or CA stenting);
- Patients listed for heart transplant;
- Patients with implanted cardiac assist device;
- Acute myocarditis;
- Infiltrative myocardial disease;
- Hypertrophic cardiomyopathy;
- Severe primary stenosis or regurgitation of the mitral, tricuspid and 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;
- Patients unable or unwilling to cooperate within the study protocol;
- Patients with rheumatic heart disease;
- Mechanic tricuspid valve patients;
- Patients with any serious medical condition that could interfere with this study;
- Enrollment in another investigational drug or device study;
- Patients not available for follow-up;
- Patients with severe chronic kidney disease (estimated glomerular filtration rate ˂ 30 ml/min/1.73 m2);
- Life expectancy ≤ 12 months;
- Participation in another telemonitoring concept.
Where it is running
1 location listed.
- Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences - Tomsk, Russia