Left Bundle Branch Pacing in Patients With Hypertrophic Cardiomyopathy After Myectomy (LEFTpaceHCM)

January 20, 2026 updated by: Meshalkin Research Institute of Pathology of Circulation

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:

  1. To analyze the safety of ICD implantation procedures with LBBB pacing in patients with HCM and LBBB after myectomy at high risk of SCD;
  2. To develop a technique for LBBB lead implantation in patients with HCM and LBBB after myectomy;
  3. 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;
  4. 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;
  5. 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;
  6. 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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:

  1. Complications related to the ICD implantation procedure;
  2. 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:

  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.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Russia
    • Novosibirsk Oblast
      • Novosibirsk, Novosibirsk Oblast, Russia, 630055
        • Recruiting
        • Meshalkin Scientific Research Center of the Ministry of Health of Russia
        • Contact:
        • Sub-Investigator:
          • Alexander V. Bogachev-Prokofiev, DMS, MD
        • Sub-Investigator:
          • Alexander V. Afanasyev, DMS, MD
        • Principal Investigator:
          • Valentina S Kirilova, PhD, MD
        • Sub-Investigator:
          • Victoria O. Andreeva, MD
        • Sub-Investigator:
          • Toychikhodzha U. Khalkhozhaev, MD
        • Sub-Investigator:
          • Alexey A. Filippenko, PhD, MD
        • Sub-Investigator:
          • Sergey I. Zheleznev, DMS, MD
        • Sub-Investigator:
          • Vitaly V. Shabanov, PhD, MD
        • Sub-Investigator:
          • Elena N. Pavlyukova, DMS, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • 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;

Exclusion criteria:

  • 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;
  • 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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1: 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
Device: ICD with left bundle branch area pacing (LBBAP)

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.
Other Names:
  • Left bundle branch block (LBBB) pacing
Active Comparator: Group 2: Dual-chamber cardioverter-defibrillator
Participants assigned to Group 2 will implantation of a dual-chamber cardioverter-defibrillator
Device: dual-chamber ICD
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Serious Adverse Events
Time Frame: 48 hours
Absence of procedural complications requiring emergency surgical intervention (major bleeding, pneumothorax, tamponade, etc.)
48 hours
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.
3-6-12 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
  • 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);
3-6-12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Meshalkin Research Institute of Pathology of Circulation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 14, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 1, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 02-5/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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