Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT05769036

Conventional Biventricular Versus Left Bundle Branch Pacing on Outcomes in Heart Failure Patients

Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences

View on ClinicalTrials.gov

Summary

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.

Official title: Randomized Study of Integrated Evaluation of Conventional Biventricular and Left Bundle Branch Pacing Therapy Effect on Left Ventricular Remodeling and Clinical Outcomes in Patients With Chronic Heart Failure With Reduced Ejection Fraction

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-10-01

Completion Date

2028-09-01

Last Updated

2025-09-10

Healthy Volunteers

Conditions

Heart Failure Left Bundle-Branch Block Ischemic Cardiomyopathy Non-ischemic Dilated Cardiomyopathy Left Ventricular Dysfunction Left Ventricular Dyssynchrony Left Ventricle Remodeling

Interventions

DEVICE

Implantation of Cardioverter-defibrillator with a Resynchronization Function Using Biventricular Pacing

The local anesthesia will be performed on the left/right subclavian area after prepping the skin. A horizontal incision will be performed. The cephalic and subclavian veins will be used to leads deliver. The active-fixation defibrillation lead will be placed to the apex/interventricular septum. The atrial active-fixation lead will be implanted to the right atrial appendage/interatrial septum. The implantation of the left ventricular pacing lead will be performed by cannulating one of the tributaries of the coronary sinus using delivery system. Leads will be fixated, connected with CRT-D device and placed in subcutaneous (subfascial prepectoral)/submuscular pocket. The pocket will be closed by separate stitches (2-4 suffice) using the resorbable braided suture. Cardioverter-defibrillator with a resynchronization function will be programmed for biventricular pacing.

DEVICE

Implantation of Cardioverter-defibrillator with a Resynchronization Function Using Left Bundle Branch Pacing

The local anesthesia will be performed on the left/right subclavian area after prepping the skin. A horizontal incision will be performed. The cephalic and subclavian veins will be used to leads deliver. The active-fixation defibrillation lead will be placed to the apex/interventricular septum. The atrial active-fixation lead will be implanted to the right atrial appendage/interatrial septum. The implantation to the left bundle branch will be performed by using special delivery system. Leads will be fixated, connected with CRT-D device and placed in subcutaneous (subfascial prepectoral)/submuscular pocket. The pocket will be closed by separate stitches (2-4 suffice) using the resorbable braided suture. Cardioverter-defibrillator with a resynchronization function will be programmed left bundle branch pacing.

Inclusion criteria: 1. The patient is willing and able to comply with the protocol and has provided written informed consent; 2. Male or female patients aged 18 to 80 years; 3. Patients with ischemic or non-ischemic cardiomyopathy; 4. Symptomatic HF for at least 3 months prior to enrollment in the study; 5. New York Heart Association (NYHA) functional class HF ≥ II; 6. 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; 7. 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; 8. 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; 9. 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); 10. Patients with HF, LVEF \< 40% (measured in the last 6 weeks prior to enrollment) and indications for continuous ventricular pacing due to bradycardia; 11. 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; 12. Optimal HF medical therapy. Exclusion criteria: 1. Coronary artery (CA) bypass grafting, balloon dilatation or CA stenting within 3 months prior to enrollment; 2. Acute myocardial infarction within 3 months prior to enrollment; 3. Acute coronary syndrome; 4. Patients with planned cardiovascular intervention (CA bypass grafting, balloon dilatation or CA stenting); 5. Patients listed for heart transplant; 6. Patients with implanted cardiac assist device; 7. Acute myocarditis; 8. Infiltrative myocardial disease; 9. Hypertrophic cardiomyopathy; 10. Severe primary stenosis or regurgitation of the mitral, tricuspid and aortic valves; 11. Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertility age; 12. Mental or physical inability to participate in the study; 13. Patients unable or unwilling to cooperate within the study protocol; 14. Patients with rheumatic heart disease; 15. Mechanic tricuspid valve patients; 16. Patients with any serious medical condition that could interfere with this study; 17. Enrollment in another investigational drug or device study; 18. Patients not available for follow-up; 19. Patients with severe chronic kidney disease (estimated glomerular filtration rate ˂ 30 ml/min/1.73 m2); 20. Life expectancy ≤ 12 months; 21. Participation in another telemonitoring concept.

Locations (1)

Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences

Tomsk, Russia