Comparing Biventricular Pacing and Left Bundle Branch Pacing for Heart Failure

Randomized Study of Integrated Evaluation of Conventional Biventricular and Left Bundle Branch Pacing Therapy Effect on Left Ventricular Remodeling and Clinical Outcomes in Patients With Chronic Heart Failure With Reduced Ejection Fraction

This study is testing whether a new way of pacing the heart can help people with heart failure feel better and improve their heart function compared to the standard method.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences (other)
• Locations: 1 site (Tomsk)
• Trial ID: NCT05769036 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the outcomes of conventional biventricular pacing with left bundle branch pacing in patients suffering from heart failure. It focuses on individuals with ischemic and non-ischemic cardiomyopathy who have reduced left ventricular function and left bundle branch block. The study will involve the implantation of cardioverter-defibrillators equipped with either pacing method to assess their effectiveness in improving heart function and patient quality of life. The trial will monitor various clinical parameters and patient responses over time to determine which pacing strategy yields better results.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 80 with symptomatic heart failure and specific heart function criteria.

Not a fit: Patients with heart failure who do not meet the inclusion criteria, such as those with certain arrhythmias or higher left ventricular ejection fractions, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for heart failure patients, enhancing their quality of life and reducing hospitalizations.

How similar studies have performed: Other studies have shown promising results with similar pacing approaches, suggesting potential for success in this trial.

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.

Where this trial is running

Tomsk

• Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences — Tomsk, Russia (RECRUITING)

Study contacts

• Principal investigator: Tariel A Atabekov, Ph.D. — Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
• Study coordinator: Tariel A Atabekov, Ph.D.

Conditions: Heart Failure, Left Bundle-Branch Block, Ischemic Cardiomyopathy, Non-ischemic Dilated Cardiomyopathy, Left Ventricular Dysfunction, Left Ventricular Dyssynchrony, Left Ventricle Remodeling, Cardiac Resynchronization Therapy