HCM - Hypertrophic CardiomyopathyLEFTpaceHCMNCT07372196
Left Bundle Branch Pacing in Patients With Hypertrophic Cardiomyopathy After Myectomy
A study testing ICD with left bundle branch area pacing (LBBAP) and dual-chamber ICD in people with HCM - Hypertrophic Cardiomyopathy and Sudden Cardiac Death, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HCM - Hypertrophic Cardiomyopathy, Sudden Cardiac Death, Left Bundle Branch Pacing
- What is being tested?
- ICD with left bundle branch area pacing (LBBAP) and dual-chamber ICD
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteRussia
- Study dates
- 14 Nov 2025to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 18 years and older;
- Patients with post-myectomy HCM who develop LBBB with a QRS complex greater than 130 ms and a high risk of SCD (HCM Risk-SCD ≥ 6%);
- Signed informed consent to participate in the study;
Who cannot join
- Absence of QRS complex morphology consistent with LBBB in LBBB with a positive QRS complex less than 130 ms;
- Presence of baseline complete RBBB;
- Heart transplantation or implantation of an LVAD is planned within the next 6 months;
- Patients with intermediate or low risk of SCD;
- History of AMI less than three months prior to study inclusion;
- Acute renal and hepatic failure;
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- Acute infectious diseases;
- Presence of mental illness;
- Presence of other illnesses for which life expectancy is less than one year;
- Patient refusal to participate in the study at any stage;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Meshalkin Scientific Research Center of the Ministry of Health of Russia
Novosibirsk, Novosibirsk Oblast, 630055
Valentina Sergeevna Kirilova, PhD, MD, 79044714203, kirilova_v@meshalkin.ru
Alexander V. Bogachev-Prokofiev, DMS, MD
About this study
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.
Read more
Objectives of the study:
- To analyze the safety of ICD implantation procedures with LBBB pacing in patients with HCM and LBBB after myectomy at high risk of SCD;
- To develop a technique for LBBB lead implantation in patients with HCM and LBBB after myectomy;
- To conduct a comparative analysis of QRS complex duration data based on ECG data before and after surgery, LV activation time, and pacing threshold based on postoperative programming data;
- To conduct a comparative analysis of the functional class of CHF, NT-proBNP, the presence/absence of interventricular and intraventricular dyssynchrony, the degree of diastolic dysfunction, LVEF, and LV EDV based on echocardiography data before and 12 months after surgery;
- Conduct a comparative analysis of QRS complex duration data based on ECG data, LV activation time, pacing threshold, the presence of recorded episodes of AF, VT, VF, antitachycardia and shock therapy according to programming data at 3, 6, and 12 months after surgery;
- Assess quality of life before and 12 months after surgery using the KCCQ-12 questionnaire; 30 patients (15 patients in each group) will be randomly separated into 2 groups. All participants go through ICD programming at 3, 6, and 12 months after myectomy, assessment of left ventricular remodeling based on ECG and echocardiography, NT-proBNP, assessment of quality of life before surgery and 12 months after surgery.
Read the detailed description
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:
- Demographic indicators: age, gender, height, weight, body mass index;
- Disease severity: SCD risk, CHF functional class, NT-proBNP, presence/absence of interventricular and intraventricular dyssynchrony, degree of diastolic dysfunction, LVEF, LVEDV;
- Comorbidities: myocardial infarction, hypertension, diabetes mellitus, atrial fibrillation, ventricular tachycardia, chronic kidney disease, liver failure, stroke.
- The quality of life questionnaire Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Intraoperative:
- QRS complex duration according to ECG;
- LV activation time;
- Pacing threshold.
Hospitalization period:
- Complications related to the ICD implantation procedure;
- Adequate ICD function according to ECG and programming data.
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:
- Unipolar impedance. The deeper into the septum, the lower the impedance. The target impedance is at least 500 ohms.
- Change the activation pattern from LBBB to RBBB.
- Initially, an increase, then a decrease in the unipolar signal. Fix the electrode with invisible U-shaped sutures. Control programming. Layered wound closure.
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.
- Conditions
- HCM - Hypertrophic Cardiomyopathy, Sudden Cardiac Death, Left Bundle Branch Pacing, ICD, Heart Failure (HF)
- Being tested
- ICD with left bundle branch area pacing (LBBAP), dual-chamber ICD
- Keywords
- sudden cardiac death, Hypertrophic Cardiomyopathy, Left Bundle Branch Pacing, ICD, Heart failure, myectomy
- Medical subject headings
- Cardiomyopathy, Hypertrophic, Death, Sudden, Cardiac, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICD with left bundle branch area pacing (LBBAP)Device
Also called Left bundle branch block (LBBB) 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:
- Unipolar impedance. The deeper into the septum, the lower the impedance. The target impedance is at least 500 ohms.
- Change the activation pattern from LBBB to RBBB.
- Initially, an increase, then a decrease in the unipolar signal. Fix the electrode with invisible U-shaped sutures. Control programming. Layered wound closure.
dual-chamber ICDDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Left bundle branch area pacing (LBBAP) | Experimental | Participants assigned to Group 1 will implantation of a dual-chamber cardioverter-defibrillator with left bundle branch block pacing Receives: Device: ICD with left bundle branch area pacing (LBBAP) |
| Group 2: Dual-chamber cardioverter-defibrillator | Active comparator | Participants assigned to Group 2 will implantation of a dual-chamber cardioverter-defibrillator Receives: Device: dual-chamber ICD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious Adverse Events
Absence of procedural complications requiring emergency surgical intervention (major bleeding, pneumothorax, tamponade, etc.)
Measured: 48 hours
Efficiency
Technical Success of the Procedure
- 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.
- QRS morphology consistent with conduction system pacing: rSR', rSr', or qR pattern in lead V1.
Time Frame: At the time of implantation.
Measured: 3-6-12 month
Secondary outcomes (1)
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);
Measured: 3-6-12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start14 Nov 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCM - Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07372196
- Sponsor's protocol ID
- 02-5/2025
- Acronym
- LEFTpaceHCM
- Status last verified
- Jan 2026
- First submitted
- 1 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Bundle Branch Pacing in Patients With Hypertrophic Cardiomyopathy After Myectomy
- ClinicalTrials.gov ID
- NCT07372196
- Acronym / sponsor ID
- LEFTpaceHCM / 02-5/2025
- Conditions
- HCM - Hypertrophic Cardiomyopathy, Sudden Cardiac Death, Left Bundle Branch Pacing, ICD, Heart Failure (HF)
- Keywords
- sudden cardiac death, Hypertrophic Cardiomyopathy, Left Bundle Branch Pacing, ICD, Heart failure, myectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- 14 Nov 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To analyze the safety of ICD implantation procedures with LBBB pacing in patients with HCM and LBBB after myectomy at high risk of SCD;
- To develop a technique for LBBB lead implantation in patients with HCM and LBBB after myectomy;
- To conduct a comparative analysis of QRS complex duration data based on ECG data before and after surgery, LV activation time, and pacing threshold based on postoperative programming data;
- To conduct a comparative analysis of the functional class of CHF, NT-proBNP, the presence/absence of interventricular and intraventricular dyssynchrony, the degree of diastolic dysfunction, LVEF, and LV EDV based on echocardiography data before and 12 months after surgery;
- Conduct a comparative analysis of QRS complex duration data based on ECG data, LV activation time, pacing threshold, the presence of recorded episodes of AF, VT, VF, antitachycardia and shock therapy according to programming data at 3, 6, and 12 months after surgery;
- Assess quality of life before and 12 months after surgery using the KCCQ-12 questionnaire; 30 patients (15 patients in each group) will be randomly separated into 2 groups. All participants go through ICD programming at 3, 6, and 12 months after myectomy, assessment of left ventricular remodeling based on ECG and echocardiography, NT-proBNP, assessment of quality of life before surgery and 12 months after surgery.
Detailed description
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:
- Demographic indicators: age, gender, height, weight, body mass index;
- Disease severity: SCD risk, CHF functional class, NT-proBNP, presence/absence of interventricular and intraventricular dyssynchrony, degree of diastolic dysfunction, LVEF, LVEDV;
- Comorbidities: myocardial infarction, hypertension, diabetes mellitus, atrial fibrillation, ventricular tachycardia, chronic kidney disease, liver failure, stroke.
- The quality of life questionnaire Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Intraoperative:
- QRS complex duration according to ECG;
- LV activation time;
- Pacing threshold.
Hospitalization period:
- Complications related to the ICD implantation procedure;
- Adequate ICD function according to ECG and programming data.
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:
- Unipolar impedance. The deeper into the septum, the lower the impedance. The target impedance is at least 500 ohms.
- Change the activation pattern from LBBB to RBBB.
- Initially, an increase, then a decrease in the unipolar signal. Fix the electrode with invisible U-shaped sutures. Control programming. Layered wound closure.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Left bundle branch area pacing (LBBAP) | Experimental | Device: ICD with left bundle branch area pacing (LBBAP)Participants assigned to Group 1 will implantation of a dual-chamber cardioverter-defibrillator with left bundle branch block pacing |
| Group 2: Dual-chamber cardioverter-defibrillator | Active comparator | Device: dual-chamber ICDParticipants assigned to Group 2 will implantation of a dual-chamber cardioverter-defibrillator |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women aged 18 years and older;
- Patients with post-myectomy HCM who develop LBBB with a QRS complex greater than 130 ms and a high risk of SCD (HCM Risk-SCD ≥ 6%);
- Signed informed consent to participate in the study;
Key exclusion criteria (10 listed)
- Absence of QRS complex morphology consistent with LBBB in LBBB with a positive QRS complex less than 130 ms;
- Presence of baseline complete RBBB;
- Heart transplantation or implantation of an LVAD is planned within the next 6 months;
- Patients with intermediate or low risk of SCD;
- History of AMI less than three months prior to study inclusion;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICD with left bundle branch area pacing (LBBAP)Also: Left bundle branch block (LBBB) pacingIncision 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. | Device | Group 1: Left bundle branch area pacing (LBBAP) |
| dual-chamber ICDUnder 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. | Device | Group 2: Dual-chamber cardioverter-defibrillator |
Primary outcome
Serious Adverse Events
Time frame: 48 hours
Absence of procedural complications requiring emergency surgical intervention (major bleeding, pneumothorax, tamponade, etc.)
Efficiency
Time frame: 3-6-12 month
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.
1 secondary outcome
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
Time frame: 3-6-12 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICD with left bundle branch area pacing (LBBAP) and dual-chamber ICD in people with HCM - Hypertrophic Cardiomyopathy and Sudden Cardiac Death, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valentina Sergeevna Kirilova, PhD, MD (+79044714203, kirilova_v@meshalkin.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious Adverse Events (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.