An interventional study of ICD with left bundle branch area pacing (LBBAP) and dual-chamber ICD in HCM - Hypertrophic Cardiomyopathy, Sudden Cardiac Death and Left Bundle Branch Pacing, sponsored by Meshalkin Research Institute of Pathology of Circulation. Recruiting at 1 site in Russia. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-28.
Sponsored by Meshalkin Research Institute of Pathology of Circulation · Not applicable, Interventional, and Prevention
Pilot interventional randomized clinical trial to study the efficacy of left bundle branch pacing in patients with hypertrophic cardiomyopathy after myectomy for the prevention of progression of heart failure, prevent the occurrence of life-threatening rhythm disturbances and promote reverse remodeling of the LV.
The aim of the study is to evaluate the comparative efficacy and safety of implantation of a cardioverter-defibrillator with left bundle branch block pacing and a dual-chamber cardioverter-defibrillator in patients with HCM and complete left bundle branch block after myectomy at high risk of SCD.
Objectives of the study:
After a discussion about the possibility of participating in the study, the patient is presented with an informed consent form and all questions of interest are explained. If consent to participate in the study is obtained, the patient and the researcher fill in all the required fields of two copies of the informed consent form and sign it. If necessary, the researcher re-explains any information regarding the study. Once informed consent has been obtained, an Individual Registration Card (IRC) is completed for the patient enrolled in the study. Completion of the IRC also continues until the completion of all stages of the study.
30 patients (15 patients in each group) will be randomly separated into 2 groups: dual-chamber ICD and a dual-chamber ICD with LBB pacing.
Initial data:
Intraoperative:
Hospitalization period:
ICD Implantation with Left Bundle Branch Pacing: Incision in the left or right connector area parallel to the key. Vein puncture. Electrodes are passed through the introducer system. Before implantation, a safety electrode is implanted in the LBBB at the apex of the right ventricle.
The His bundle is recorded 1-1.5 cm apically (toward the apex of the right ventricle) in the area of the interventricular septum. Pacing from this area of the QRS complex in lead V1 has a "W" morphology. Insert the electrode into the thick interventricular septum. After each ventricular extrasystole, stop inserting and measure the following parameters:
Statistical analysis:
Comparisons of continuous outcomes will be performed using the Mann-Whitney test for non-normal variables and the Welch t-test for normal variables. Comparisons of binary outcomes will be performed using the chi-square test or Fisher's exact test.
363 studies on the registry are indexed under Cardiomyopathy, Hypertrophic; 116 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 180 interventional studies indexed under Cardiomyopathy, Hypertrophic.
Browse Cardiomyopathy, Hypertrophic studies →Meshalkin Research Institute of Pathology of Circulation is the lead sponsor of 119 studies on the registry; 9 are open to participants now.
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Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Life expectancy
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to Group 1 will implantation of a dual-chamber cardioverter-defibrillator with left bundle branch block pacing
Device: ICD with left bundle branch area pacing (LBBAP)
Participants assigned to Group 2 will implantation of a dual-chamber cardioverter-defibrillator
Device: dual-chamber ICD
Incision in the left or right connector area parallel to the key. Vein puncture. Electrodes are passed through the introducer system. Before implantation, a safety electrode is implanted in the LBBB at the apex of the right ventricle. The His bundle is recorded 1-1.5 cm apically (toward the apex of the right ventricle) in the area of the interventricular septum. Pacing from this area of the QRS complex in lead V1 has a "W" morphology. Insert the electrode into the thick interventricular septum. After each ventricular extrasystole, stop inserting and measure the following parameters: 1. Unipolar impedance. The deeper into the septum, the lower the impedance. The target impedance is at least 500 ohms. 2. Change the activation pattern from LBBB to RBBB. 3. Initially, an increase, then a decrease in the unipolar signal. Fix the electrode with invisible U-shaped sutures. Control programming. Layered wound closure.
Also known as: Left bundle branch block (LBBB) pacing
Under local anesthesia, an incision was made parallel to the clavicle in the left junctional area. A subcutaneous bed for the pacemaker was created. Hemostasis was maintained. The communicating vein was punctured from the wound, and through a system of introducers, it was continuously fixed in the right ventricular septum under fluoroscopic control. The electrode was fixed with a U-shaped suture. The communicating vein was again punctured, and through the system of introducers, an electrode was inserted, which was firmly fixed in the right atrial appendage under fluoroscopic control. The electrode was fixed with a U-shaped suture. The electrodes are connected to the pacemaker. Layered wound suturing is performed. An aseptic dressing is applied.
Serious Adverse Events
Absence of procedural complications requiring emergency surgical intervention (major bleeding, pneumothorax, tamponade, etc.)
Time frame: 48 hours
Efficiency
Technical Success of the Procedure 1. Reduction in QRS Duration Decrease in paced QRS duration by ≥ 20 ms compared with the baseline intrinsic QRS duration during complete left bundle branch block. Time Frame: At the time of implantation. 2. QRS morphology consistent with conduction system pacing: rSR', rSr', or qR pattern in lead V1. Time Frame: At the time of implantation.
Time frame: 3-6-12 month
Hospitalization for heart failure, assessment of the functional class of CH, measurement of NT-proBNP, assessment of LV remodeling, antitachycardia and shock therapy, paroxysms of supraventricular tachycardia, quality of life
* Hospitalization for heart failure within 12 months after ICD implantation; * Assessment of the functional class of CHF according to the NYHA classification at 12 months; * Measurement of NT-proBNP at 12 months after ICD implantation; * Assessment of LV remodeling (presence/absence of interventricular and intraventricular dyssynchrony) at 12 months; * Assessment of left ventricular end-diastolic volume at 12 months; * Assessment of left ventricular ejection fraction at 12 months; * Antitachycardia and shock therapy according to ICD programming data at 12 months; * Registered paroxysms of supraventricular tachycardia according to ICD programming data at 12 months; * Assessment of quality of life using the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) at 12 months (0 to 24 = very poor to poor; 25 to 49 = poor to fair; 50 to 74 = fair to good; and 75 to 100 = good to excellent);
Time frame: 3-6-12 month
Plan to share: No
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