Comparing Biventricular Pacing and Left Bundle Branch Pacing for Heart Failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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.
• Email: kgma1011@mail.ru
• Phone: +79528002625

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.