New pacemaker technique aims to boost heart failure treatment
NCT ID NCT05769036
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests whether a newer pacing method called left bundle branch pacing (LBBP) works better than the standard biventricular pacing for people with chronic heart failure and reduced pumping ability. About 60 adults with heart failure and a specific electrical delay in the heart will receive a special pacemaker-defibrillator using one of the two techniques. The goal is to see if LBBP can improve heart function, reduce hospitalizations, and lower the risk of death.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cardiac resynchronization therapy device (pacemaker/defibrillator) with left bundle branch pacing or biventricular pacing
- What this could lead to
- If successful, this could offer a more effective pacing method for heart failure patients, potentially reducing hospitalizations and improving heart function compared to current standard therapy.
- What could go wrong
- This is a small, early-stage study with only 60 participants, so results may not apply to all patients. The new pacing method may not prove superior or could have unforeseen complications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2023
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
RECRUITINGTomsk, Russia
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