Left Bundle Branch Pacing on Outcomes and Ventricular Remodeling in Biventricular CRT Nonresponders

RECRUITING

NCT05760924

NA

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

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 the 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 device for cardiac resynchronization therapy 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. Cardiac conduction system pacing is currently a promising technique for these patients. Particularly, His bundle pacing (HBP) has been developed to achieve the same results. According to other studies HBP has shown greater improvement in hemodynamic parameters comparing with conventional biventricular CRT. But, nevertheless, there are significant clinical troubles with HBP, especially high pacing threshold. In this regard, in 2017, the left bundle branch pacing (LBBP) was developed, which demonstrated clinical advantages compared to conventional biventricular CRT. Also, since 2019, left bundle branch pacing-optimized CRT (LBBPO CRT) has been used in clinical practice. These methods have become an alternative to HBP due to the stimulation of LBB outside the blocking site, a stable pacing threshold and a narrow QRS complex duration on electrocardiogram. A series of case reports and observational studies have demonstrated the efficacy and safety of LBBP and LBBPO CRT in patients with CRT indications. However, it is not enough data about impact of CRT with LBBP and combined CRT with LBBP and LV pacing on myocardial remodeling, reducing mortality and complications. According to our hypothesis, CRT with LBBP and combined CRT with LBBP and LV pacing compared with conventional biventricular pacing will significantly improve the clinical outcomes and reverse myocardial remodeling in patients who are non-responders to biventricular CRT with HF, reduced LV ejection fraction and with indications to CRT devices with defibrillator function (CRT-D) or one of the CRT-D leads replacement.

Official title: Randomized Trial of Left Bundle Branch Pacing Effect on Clinical Outcomes and Left Ventricular Remodeling in Patients With Nonresponse to Biventricular Cardiac Resynchronization Therapy

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2024-11-01

Completion Date

2028-09-01

Last Updated

2024-11-22

Healthy Volunteers

No

Conditions

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

Interventions

DEVICE

Cardiac Resynchronization Therapy Devices with Defibrillator Function (CRT-D) or CRT-D Leads Replacement

The local anesthesia will be performed on the left/right subclavian area after prepping the skin. The device pocket will be opened, the old CRT-D will be removed and disconnected from the leads. The pacing threshold, intracardiac signal amplitude and impedance (pacing and shock) on the atrial, defibrillation and left ventricular leads will be performed. If there is a lead dysfunction, the new lead will be implanted. The new CRT-D will be connected with leads and placed back into the pocket. The pocket will be closed by separate stitches (2-4 suffice) using the resorbable braided suture.

DEVICE

CRT-D or CRT-D Leads Replacement with New Lead Implantation to Left Bundle Branch and Inactivation of Conventional Right and Left Ventricular Pacing

The local anesthesia will be performed on the left/right subclavian area after prepping the skin. The device pocket will be opened, the old CRT-D will be removed and disconnected from the leads. The pacing threshold, intracardiac signal amplitude and impedance (pacing and shock) on the atrial, defibrillation and left ventricular leads will be performed. If there is a lead dysfunction, the new lead will be implanted. The lead implantation to the left bundle branch (LBB) will be performed by transvenous approach and special delivery system. The new CRT-D will be connected with the leads (LBB pacing lead will be connected to defibrillation lead (DL) IS-1 connector of CRT-D and IS-1 tip of DL will be capped) and placed back into pocket. The pocket will be closed by separate stitches (2-4 suffice) using the resorbable braided suture. RV and LV pacing will be inactivated and only LBB pacing will be switched on.

DEVICE

CRT-D or CRT-D Leads Replacement with New Lead Implantation to Left Bundle Branch and Inactivation of Conventional Right Ventricular Pacing

The local anesthesia will be performed on the left/right subclavian area after prepping the skin. The device pocket will be opened, the old CRT-D will be removed and disconnected from the leads. The pacing threshold, intracardiac signal amplitude and impedance (pacing and shock) on the atrial, defibrillation and left ventricular leads will be performed. If there is a lead dysfunction, the new lead will be implanted. The lead implantation to the left bundle branch (LBB) will be performed by transvenous approach and special delivery system. The new CRT-D will be connected with the leads (LBB pacing lead will be connected to defibrillation lead (DL) IS-1 connector of CRT-D and IS-1 tip of DL will be capped) and placed back into pocket. The pocket will be closed by separate stitches (2-4 suffice) using the resorbable braided suture. LBB and LV pacing will be switched on.

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 who are non-responders to biventricular CRT with HF, reduced LVEF and CRT-D replacement or one of the CRT-D leads replacement indications (without LVEF increase ≥ 5% and/or without a left ventricle end-systolic volume decrease ≥ 15% after CRT-D implantation at least 1 year old); 7. 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

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