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

Launched by TOMSK NATIONAL RESEARCH MEDICAL CENTER OF THE RUSSIAN ACADEMY OF SCIENCES · Mar 2, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a new approach to treating heart failure (HF) patients who have a specific heart rhythm problem called left bundle branch block (LBBB). The researchers want to compare two methods of pacing the heart: the traditional biventricular pacing and a newer technique called left bundle branch pacing (LBBP). They hope that LBBP will improve heart function, reduce symptoms of heart failure, and help more patients respond positively to treatment.

To participate in this trial, you need to be between 18 and 80 years old and have been experiencing heart failure symptoms for at least three months. You should also have a weakened heart (with a left ventricular ejection fraction of 35% or less) and specific heart rhythm characteristics. Participants will receive the pacing treatment and be monitored for improvements in their heart health and quality of life. This trial is currently recruiting participants, and it aims to provide valuable information about the effectiveness of LBBP compared to standard treatments.

Gender

ALL

Eligibility criteria

• 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 with HF in sinus rhythm (SR) with LVEF ≤ 35% (measured in the last 6 weeks prior to enrollment), QRS duration ≥150 ms with LBBB morphology;
• • 7. Patients with HF in SR with LVEF ≤ 35% (measured in the last 6 weeks prior to enrollment), QRS duration 130-149 ms with LBBB morphology;
• • 8. Patients with HF in SR with LVEF ≤ 35% (measured in the last 6 weeks prior to enrollment), QRS duration ≥150 ms with non-LBBB morphology;
• • 9. Patients with symptomatic persistent or permanent atrial fibrillation, HF with LVEF \< 40% (measured in the last 6 weeks prior to enrollment) and an uncontrolled heart rate who are candidates for atrioventricular junction ablation (irrespective of QRS duration);
• • 10. Patients with HF, LVEF \< 40% (measured in the last 6 weeks prior to enrollment) and indications for continuous ventricular pacing due to bradycardia;
• • 11. Patients who have received a conventional pacemaker or an implanted cardioverter-defibrillator and who subsequently develop symptomatic HF with LVEF \< 40% (measured in the last 6 weeks prior to enrollment) despite optimal medical therapy, and who have a significant proportion of right ventricle pacing;
• • 12. 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.