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

Launched by TOMSK NATIONAL RESEARCH MEDICAL CENTER OF THE RUSSIAN ACADEMY OF SCIENCES · Mar 5, 2023

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ClinConnect Summary

This clinical trial is studying a new heart treatment called left bundle branch pacing (LBBP) for patients with heart failure who have not responded to standard therapies. Heart failure can make it hard for the heart to pump blood effectively, leading to symptoms like fatigue and shortness of breath. The trial aims to see if LBBP can improve heart function and overall health in patients who have not seen benefits from conventional biventricular cardiac resynchronization therapy (CRT), a common treatment that helps coordinate heartbeats.

To participate, individuals need to be between 18 and 80 years old and have heart failure symptoms for at least three months. They should also have already tried biventricular CRT without significant improvement in their heart function. Participants will be closely monitored during the study and may experience improved heart function and quality of life. It's important to note that certain health conditions, recent heart procedures, or plans for surgery may exclude individuals from joining the trial.

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 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.