An interventional study of Implantation of Cardioverter-defibrillator with a Resynchronization Function Using Biventricular Pacing and Implantation of Cardioverter-defibrillator with a Resynchronization Function Using Left Bundle Branch Pacing in Heart Failure, Left Bundle-Branch Block and Ischemic Cardiomyopathy, sponsored by Tomsk National Research Medical Center of the Russian Academy of Sciences. Recruiting at 1 site in Russia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-09-10.
Sponsored by Tomsk National Research Medical Center of the Russian Academy of Sciences · Not applicable, Interventional, and Treatment
Heart failure (HF) is the most common nosology encountered in clinical practice. Its incidence and prevalence increase exponentially with increasing age and it is associated with increased mortality, more frequent hospitalization and decreased quality of life. An initial approach to the treatment of HF patients with reduced left ventricular (LV) systolic function and left bundle branch block (LBBB) was implantation of cardioresynchronization device using biventricular pacing. This has resulted in long-term clinical benefits such as improved quality of life, increased functional capacity, reduced HF hospitalizations and overall mortality. However, conventional cardiac resynchronization therapy (CRT) is effective in only 70% of patients. And the remaining 30% of patients are non-responders to conventional CRT. Subsequently, His bundle pacing (HBP) has been developed to achieve the same results. According to other studies HBP has showed greater improvement in hemodynamic parameters than with conventional biventricular CRT. But, nevertheless, there are significant clinical troubles with HBP. In this regard, in 2017, the left bundle branch pacing (LBBP) was developed, which demonstrated clinical advantages compared to biventricular CRT. This method has become an alternative to HBP due to the stimulation of LBB outside the blocking site, a stable pacing threshold and a narrow QRS duration. A series of case reports and observational studies have demonstrated the efficacy and safety of LBBP in patients with CRT indications. However, it is not enough data about CRT with LBBP effectiveness in LV remodeling, reducing mortality and complications. According to our hypothesis, CRT with LBBP compared with conventional biventricular CRT will significantly improve the clinical outcomes and reverse LV remodeling in patients with chronic HF with reduced LV ejection fraction and reduce the number of non-responders to conventional CRT.
The heart failure (HF) is a rapidly growing public health issue with an estimated prevalence of more than 37.7 million individuals globally. In the developed world, this disease affects approximately 2.0% of the adult population. In the United States the total percentage of the population with HF is projected to rise from 2.4% in 2012 to 3.0% in 2030. In Russian Federation the prevalence of chronic HF (CHF) is 10.2%. The main cause of CHF is a coronary heart disease, which accounts for about 70.0%, and the remaining 30.0% are non-ischemic heart diseases. More than 2 decades of research has established the role of cardiac resynchronization therapy (CRT) in medically refractory, mild to severe systolic HF with abnormal QRS duration and morphology. The prolongation of QRS (120 ms or more) occurs in 14.0% to 47.0% of HF patients and the ventricular conduction disturbance, most commonly left bundle branch block (LBBB), is present in approximately one-third of HF, leading to mechanical dyssynchrony of ventricles. Prospective randomized studies of patients with both ischemic HF (IHF) and non-ischemic HF (NIHF) have shown that CRT translates into long-term clinical benefits, such as improved quality of life, increased functional capacity, reduction in hospitalization for HF, and overall mortality. These patients qualified as responders to CRT. However, CRT is effective in 70.0% of patients, and the remaining 30.0% do not respond to the device therapy. In fact, biventricular CRT leads to the fusion of two fronts of non-physiological excitation waves and leaves a significant residual dyssynchrony.
His bundle pacing (HBP) is possible alternative to biventricular CRT. During HBP there is a physiological electromechanical synchrony by facilitating conduction through the native His-Purkinje system. HBP promotes higher electrical ventricular resynchronization than biventricular CRT. Studies have shown that HBP, as well as conventional biventricular CRT, improves cardiac function, which leads to a decrease in the number of HF hospitalizations. The main unsolved problems that limit the use of HBP are the low amplitude of the intracardiac signal, high pacing thresholds and troubles associated with lead implantation in the area of the His bundle, which ultimately increases the risk of re-implantation.
In 2017, W. Huang et al. pioneered left bundle branch pacing (LBBP) and demonstrated that it provided clinical benefits in patients with HF and LBBB, aiming to pacing the proximal left bundle branch (LBB) along with LV myocardial capture. During selective pacing, only LBB is captured without the nearby myocardium, while with non-selective LBBP the septal myocardium is captured. LBBP with lead implanted slightly distal to the His bundle and screwed deep into the left ventricular (LV) septum is ideal for the LBB capture. LBBP has emerged as an alternative to HBP due to pacing of LBB outside the blocking site, a stable pacing threshold, and a narrow QRS in patients with bradycardia. In clinical cases of W. Huang et al. was demonstrated for the first time that LBBP could lead to complete correction of LBBB and improvement in cardiac function in patients with LBBB and HF. In another observational study, W. Zhang et al. showed that LBBP could be a new method of CRT. Subsequently, several case reports and observational studies have demonstrated the efficacy and safety of LBBP in patients with indications for CRT device implantation.
The above studies demonstrate that LBBP is clinically feasible in patients with HF and LBBB. However, there are still few data about CRT using LBBP in patients with HF and reduced LVEF. There are also few studies on direct comparison of changes in clinical, speckle tracking echocardiography and other laboratory and instrumental parameters between patients with conventional biventricular CRT and CRT using LBBP.
CRT induces reverse remodeling of the affected heart, improves LV systolic and diastolic function and left heart filling pressure. The measurement of fibrosis and remodeling biomarkers representing the pattern of active processes in HF be useful.
The relationship between changes in the biomarkers level and reverse remodeling process in patients with LBBP is currently poorly understood. And there are no publications regarding the correlation of the level of such biomarkers as MR-proANP, GDF-15, galectin-3, ST2, MR-proADM and PINP with clinical and instrumental indicators of patients with LBBP in the available literature. This creates all the prerequisites for studying the association of the above biomarkers with the reverse remodeling process in patients with CRT using LBBP.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 60 is below the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Tomsk National Research Medical Center of the Russian Academy of Sciences is the lead sponsor of 73 studies on the registry; 19 are open to participants now.
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The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
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GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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Investigational drug or device
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GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
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Patients in this group will be implanted with a cardioverter-defibrillator with a resynchronization function using the biventricular pacing
Device: Implantation of Cardioverter-defibrillator with a Resynchronization Function Using Biventricular Pacing
Patients in this group will be implanted with a cardioverter-defibrillator with a resynchronization function using the left bundle branch pacing
Device: Implantation of Cardioverter-defibrillator with a Resynchronization Function Using Left Bundle Branch Pacing
The local anesthesia will be performed on the left/right subclavian area after prepping the skin. A horizontal incision will be performed. The cephalic and subclavian veins will be used to leads deliver. The active-fixation defibrillation lead will be placed to the apex/interventricular septum. The atrial active-fixation lead will be implanted to the right atrial appendage/interatrial septum. The implantation of the left ventricular pacing lead will be performed by cannulating one of the tributaries of the coronary sinus using delivery system. Leads will be fixated, connected with CRT-D device and placed in subcutaneous (subfascial prepectoral)/submuscular pocket. The pocket will be closed by separate stitches (2-4 suffice) using the resorbable braided suture. Cardioverter-defibrillator with a resynchronization function will be programmed for biventricular pacing.
The local anesthesia will be performed on the left/right subclavian area after prepping the skin. A horizontal incision will be performed. The cephalic and subclavian veins will be used to leads deliver. The active-fixation defibrillation lead will be placed to the apex/interventricular septum. The atrial active-fixation lead will be implanted to the right atrial appendage/interatrial septum. The implantation to the left bundle branch will be performed by using special delivery system. Leads will be fixated, connected with CRT-D device and placed in subcutaneous (subfascial prepectoral)/submuscular pocket. The pocket will be closed by separate stitches (2-4 suffice) using the resorbable braided suture. Cardioverter-defibrillator with a resynchronization function will be programmed left bundle branch pacing.
All-cause mortality or worsening of heart failure requiring unplanned hospitalization (%)
Definition of all-cause mortality All deaths and all heart transplants due to the terminal heart failure. Heart transplanted patients will be dropped out and followed in respect of their vital status for the duration of the study. Definition of worsening of heart failure requiring unplanned hospitalization Patients requiring intra-venous medication for heart failure (including diuretics, vasodilators or inotropic agents) or a substantial increase in oral diuretic therapy for heart failure (i. e. an increase of Furosemide ≥ 40 mg or equivalent, or the addition of a thiazide to a loop diuretic) will be deemed to have worsening of heart failure. Further, rales and/or S3 sound, chest x-ray, worsening of dyspnoea, worsening of peripheral edema and increase of class NYHA will be assessed for determination of worsening of heart failure. Unplanned hospitalization is defined as any in-hospital stay over one date change, and not planned by the Investigator.
Time frame: 24 months
All-cause Mortality (%)
As defined for primary endpoint: all deaths and all heart transplants because of terminal heart failure.
Time frame: 24 months
Cardiovascular Mortality (%)
All deaths due to cardiovascular reasons and all heart transplants because of terminal HF. Deaths due to worsening of HF, acute coronary syndrome, cerebrovascular accidents, or other cardiovascular events will qualify for this secondary endpoint.
Time frame: 24 months
Worsening of Heart Failure Requiring Unplanned Hospitalization (%)
As defined for the primary end-point: patients requiring intra-venous medication for HF (including diuretics, vasodilators, or inotropic agents) or a substantial increase in oral diuretic therapy for HF (i. e. an increase of Furosemide ≥ 40 mg or equivalent, or the addition of a thiazide to a loop diuretic) will be deemed to have worsening of HF. Further, rales and/or S3 sound, chest x-ray, worsening of dyspnoea, worsening of peripheral edema, and increase of class NYHA will be assessed for determination of worsening of HF. Unplanned hospitalization is defined as any in-hospital stay over one date change, and not planned by the Investigator. Reasons for worsening of HF may include AF, acute coronary syndrome and hypertension.
Time frame: 24 months
Unplanned Hospitalization due to Cardiovascular Reason (%)
Any in-hospital stay over one date change due to cardiovascular reason, which includes worsening of HF, acute coronary syndrome, cerebrovascular accidents, or other cardiovascular events, and not planned by the Investigator. In case the hospitalization is classified as planned by the Investigator, and the time interval between the decision to hospitalize and the hospitalization is less than 24 hours.
Time frame: 24 months
All-cause Hospitalization (%)
Any in-hospital stay over one date change.
Time frame: 24 months
Number of Delivered CRT-D Shocks (n)
An CRT-D shock is an electrical treatment consisting of a high voltage capacitor discharge delivered upon detection of VT/VF episode. All ICD shocks will be collected and classified by the Investigator as successful or non successful in respect to the termination of the tachyarrhythmia.
Time frame: 24 months
Time to First CRT-D Shock (days)
It is the time interval between the end of the 12 weeks blanking after baseline and the first appropriate CRT-D shock in case of ventricular tachycardia or ventricular fibrillation.
Time frame: 24 months
Number of Delivered CRT-D ATPs (n)
An CRT-D antitachycardia pacing therapy (ATP) is an electrical treatment consisting of timed stimuli delivered upon detection of ventricular tachycardia/ventricular fibrillation (VT/VF) episode. All CRT-D ATPs will be collected and classified by the Investigator as successful or non successful in respect to the termination of the tachyarrhythmia.
Time frame: 24 months
Time to First CRT-D ATP (days)
It is the time interval between the end of the 12 weeks blanking after baseline and the first ATP therapy.
Time frame: 24 months
Number of Device Detected VT/VF Episodes (n)
It is any ventricular tachyarrhythmia which fulfils the programmed detection criteria of the device in order to be classified as tachyarrhythmic ventricular episode. Device detected episodes will be classified by the Investigator as appropriately detected in presence of real tachyarrhythmia, or inappropriately detected in case of other reasons (oversensing, noise, fast ventricular rate due to supraventricular tachycardia).
Time frame: 24 months
Left Ventricular Function (LVEF, %)
The measurement of the left ventricular ejection fraction performed by echocardiography using the modified Simpson's rule.
Time frame: 24 months
Exercise Tolerance (m)
It is the measurement of the maximal distance that the patient is able to walk within 6 minutes.
Time frame: 24 months
Life Quality (MLWHFQ score)
The life quality is the patient's ability to enjoy normal life activities. For patients suffering from HF, improvement of quality of life is one of the most important goals of new treatments, sometimes as important as improved survival. Some medical treatments can seriously impair quality of life without providing appreciable benefit, while others greatly enhance it. To evaluate the effect of cardiac resynchronization therapy with left bundle branch pacing on the quality of life of patients, general and heart failure-related quality of life questionnaires, both filled in by each individual patient, will be used. The Minnesota Living with Heart Failure Questionnaire (MLWHFQ, scale from 0 to 5) will be used.
Time frame: 24 months
Life Quality (EuroQoL EQ-5D score)
The life quality is the patient's ability to enjoy normal life activities. For patients suffering from HF, improvement of quality of life is one of the most important goals of new treatments, sometimes as important as improved survival. Some medical treatments can seriously impair quality of life without providing appreciable benefit, while others greatly enhance it. To evaluate the effect of cardiac resynchronization therapy with left bundle branch pacing on the quality of life of patients, general and heart failure-related quality of life questionnaires, both filled in by each individual patient, will be used. The European Quality of Life Questionnaire (EuroQoL EQ-5D, scale from 0 to 100) will be used.
Time frame: 24 months
Echocardiography Left Ventricular Volume Improvement (%)
Echocardiographic measurements will be done at baseline, 6, 12, 18 and 24 month follow-up, to evaluate effect of CRT-D implantation on left ventricle (LV) volume. Improvements due to reverse remodelling of the heart will be evaluated by measuring left ventricular end-systolic volume (LVESV), which is supposed to decrease at follow-up. Further, LV volume improvment will be calculated using formula: ((A-B)/A) x 100% (A-baseline LVESV; B-follow-up LVESV).
Time frame: 24 months
Echocardiography Left Ventricular Ejection Fraction Improvement (%)
chocardiographic measurements will be done at baseline, 6, 12, 18 and 24 month follow-up, to evaluate effect of CRT-D implantation on left ventricle (LV) contractility function. Improvements due to reverse remodelling of the heart will be evaluated by measuring left ventricular ejection fraction (LVEF), which is supposed to increase at follow-up. Further, LV contractility function improvment will be calculated using formula: ((A-B)/A) x 100% (A-baseline LVEF; B-follow-up LVEF).
Time frame: 24 months
NYHA Class
The NYHA functional classification provides a simple way of classifying the extent of HF. It is based on questions, related to the usual daily activities and symptoms posed to the patients, and it will be determined at enrollment, baseline and at each FU visit. In ablated patients an improvement of NYHA class is expected, the analysis of which will help to assess the efficacy of ablation therapy.
Time frame: 24 months
Rate of Drug Support Requirements (%)
Beta-blockers, angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists, aldosterone antagonists, diuretics, and sodium-glucose transporter type 2 inhibitors, antiarrhythmics and diuretics are drugs commonly taken by patients suffering from HF. Those drugs may have the potential to induce AEs. In patients with left bundle branch pacing (LBBP) CRT-D a reduction in drug consumption is expected, with a consequent reduction of side effects. The evaluation of the drug regimen will help to assess the effectiveness of LBBP.
Time frame: 24 months
Started Oct 2023 (actual). Primary completion is estimated for Jun 2028, 56 months after the start.
Of 1,118 non-industry interventional studies with no phase under Heart Failure, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 50. This study's planned 56 months is above that.
Counting every sponsor, half of 1,354 studies reached it within 31 months; a quarter within 16 and three quarters within 52.
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Tomsk National Research Medical Center of the Russian Academy of Sciences