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

RecruitingNAAges 18 Years - 80 YearsAllTomsk National Research Medical Center of the Rusโ€ฆ
NCT05760924 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

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 tech

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๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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 โ‰ฅ 5% and/or without a left ventricle end-systolic volume decrease โ‰ฅ 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 ห‚ 30 ml/min/1.73 m2); 20. Life expectancy โ‰ค 12 months; 21. Participation in another telemonitoring concept.
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What it tests

  • Cardiac Resynchronization Therapy Devices with Defibrillator Function (CRT-D) or CRT-D Leads Replacement
  • CRT-D or CRT-D Leads Replacement with New Lead Implantation to Left Bundle Branch and Inactivation of Conventional Right and Left Ventricular Pacing
  • CRT-D or CRT-D Leads Replacement with New Lead Implantation to Left Bundle Branch and Inactivation of Conventional Right Ventricular Pacing
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Where

1 site
Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
Tomsk, Russia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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