RecruitingNot ApplicableNCT05769036

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

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


Sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Enrollment

60 participants

Start Date

Oct 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study compares two types of cardiac resynchronization therapy (a pacemaker treatment that helps the heart beat more efficiently) for patients with heart failure: the traditional biventricular pacing versus a newer method called left bundle branch pacing. **You may be eligible if...** - You are between 18 and 80 years old - You have heart failure with a significantly weakened heart (ejection fraction ≤ 35%) - Your heart is in normal sinus rhythm and your ECG shows a wide QRS with left bundle branch block pattern (≥ 150 ms) - You have had heart failure symptoms for at least 3 months - You have New York Heart Association Class II heart failure or worse **You may NOT be eligible if...** - Your heart rhythm is irregular (atrial fibrillation) - Your ejection fraction is above 35% - You have a QRS width less than 150 ms Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interventions

DEVICEImplantation 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.

DEVICEImplantation 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.


Locations(1)

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

Tomsk, Russia

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NCT05769036


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