Actively Recruiting
Study of Left Bundle Branch Pacing to Improve Heart Function and Outcomes in Patients Who Do Not Respond to Standard Biventricular Cardiac Resynchronization Therapy
Led by Tomsk National Research Medical Center of the Russian Academy of Sciences · Updated on 2024-11-22
30
Participants Needed
1
Research Sites
13 weeks
Total Duration
AI-Summary
What this Trial Is About
Heart failure HF is a common condition that increases with age and is linked to higher mortality, hospitalizations, and reduced quality of life. Cardiac resynchronization therapy CRT using biventricular pacing has been the standard treatment for HF patients with reduced left ventricular function and left bundle branch block LBBB. However, about 30% of patients do not respond to conventional CRT, prompting investigation into alternative pacing methods such as His bundle pacing HBP and left bundle branch pacing LBBP, with emerging evidence suggesting benefits from these newer techniques. This trial compares three approaches for patients who do not respond to conventional biventricular CRT and have indications for CRT devices with defibrillator function. One group will receive standard CRT-D device replacement, another will receive CRT-D replacement with new lead implantation for left bundle branch pacing LBBP while inactivating conventional right and left ventricular pacing, and the third group will have CRT-D replacement with LBBP lead implantation and continued left ventricular pacing but inactivation of right ventricular pacing. These procedures involve device pocket opening, lead assessments, and new lead implantation under local anesthesia. Participants will be followed for 24 months to assess outcomes such as all-cause mortality or worsening heart failure requiring hospitalization, heart function via left ventricular ejection fraction, exercise tolerance, and quality of life questionnaires. Researchers will monitor device activity, hospitalizations, and biomarker levels related to heart remodeling. The study aims to evaluate whether LBBP or combined LBB and left ventricular pacing improves clinical outcomes and heart remodeling compared to conventional CRT in non-responding HF patients.
CONDITIONS
Brief Title
Left Bundle Branch Pacing on Outcomes and Ventricular Remodeling in Biventricular CRT Nonresponders
Research Team
T
Tariel A Atabekov, Ph.D.
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