Left Bundle Branch Area Pacing in Patients With Heart Failure
NCT Number: NCT06488989
Acronym: LBBAPHF
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Heart Failure With Reduced Ejection Fraction|Left Bundle Branch Area Pacing|Heart Failure|Cardiac Resynchronization Therapy|Cardiac Resynchronization Therapy Devices|Conduction System Pacing|Left Bundle-Branch Block
Interventions: DEVICE: left bundle branch area pacing
Sponsor: National Research Center for Cardiac Surgery, Kazakhstan
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-01
Completion Date: 2026-06-01
Locations: CF UMC, Astana, 010000, Kazakhstan

Summary:
The relevance of Left Bundle Branch Pacing (LBBP) lies in its potential as a promising treatment option for patients with heart failure and left bundle branch block. LBBP aims to restore the normal physiological activation of the heart by delivering electrical impulses to the anatomical area of the left bundle branch, which may lead to more effective and synchronized ventricular contractions. Compared to traditional cardiac resynchronization therapy (CRT), this can result in a more physiological correction of dyssynchrony, improvement in left ventricular pump function, reduction in left ventricular volumes, and a decrease in mitral regurgitation. A crucial criterion is the reduction of heart failure symptoms and the enhancement of the patients quality of life.

Primary Outcome Measures: General complications related to implantable cardiac device, Incidence and amount of participants with general complication (deaths, stroke, thromboembolic complications);, From enrollment to the end of follow-up period at 12 months|procedure-related complications related to implantable cardiac device, Incidence and amount of participants with procedure-related complication (pneumothorax, pocket/wound infection, systemic infection, pocket hematoma, atrial lead dislodgement, pericardial effusion, large vein thrombosis, re-intervention for other non-LBBAP lead reasons, subclavian arteriovenous fistula after puncture), From enrollment to the end of follow-up period at 12 months|LBBAP lead-related complications complications related to implantable cardiac device, Incidence and amount of patients with LBBAP lead-related complications (intraprocedural perforation into the left ventricle (LV) cavity , delayed perforation into the LV cavity, acute chest pain, acute ST-segment elevation in multiple leads, acute coronary syndrome, coronary vein fistula, coronary artery fistula, painful pacing/chest pain, right bundle branch injury, LBBAP lead unscrewable/trapped/damaged helix, LBBAP lead dislodgement, threshold rise to an absolute value \> 2 V, threshold rise \> 1 V from baseline, threshold rise leading to re-intervention), From enrollment to the end of follow-up period at 12 months|shortening of QRS, Efficacy will be evaluated by shortening of QRS duration on ECG., From enrollment to the end of follow-up period at 12 months|Improvement of left ventricle ejection fraction, Efficacy will be evaluated by increasing of left ventricle ejection fraction, measured by transthoracic echocardiography in 4 chamber apical position by Simpson's approach., From enrollment to the end of follow-up period at 12 months|Decreasing of left ventricle end-diastolic diameter, Efficacy will be evaluated by decreasing of left ventricle end-diastolic diameter measured by transthoracic echocardiography in parasternal long axis., From enrollment to the end of follow-up period at 12 months|Decreasing of left ventricle end-diastolic volume, Efficacy will be evaluated by decreasing of left ventricle end-diastolic volume measured by transthoracic echocardiography in apical 4-chamber position, From enrollment to the end of follow-up period at 12 months|Decreasing of left ventricle end-systolic volume, Efficacy will be evaluated by decreasing of left ventricle end-systolic volume measured by transthoracic echocardiography in apical 4-chamber position, From enrollment to the end of follow-up period at 12 months|Improvement of mitral regurgitation, Efficacy will be evaluated by decreasing of mitral regurgitation measured by transthoracic echocardiography in multiply positions, From enrollment to the end of follow-up period at 12 months