NCT07372196

Brief 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. 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. 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. 2.To develop a technique for LBBB lead implantation in patients with HCM and LBBB after myectomy;
  3. 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. 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. 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
14mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress29%
Nov 2025Jul 2027

Study Start

First participant enrolled

November 14, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 1, 2026

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 28, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

1.5 years

First QC Date

January 1, 2026

Last Update Submit

January 20, 2026

Conditions

HCM - Hypertrophic CardiomyopathySudden Cardiac DeathICDLeft Bundle Branch PacingHeart Failure (HF)

Keywords

sudden cardiac deathHypertrophic CardiomyopathyLeft Bundle Branch PacingICDHeart failuremyectomy

Outcome Measures

Primary Outcomes (2)

  • Serious Adverse Events

    Absence of procedural complications requiring emergency surgical intervention (major bleeding, pneumothorax, tamponade, etc.)

    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.

    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

    3-6-12 month

Study Arms (2)

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

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

Device: dual-chamber ICD

Interventions

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.

Group 2: Dual-chamber cardioverter-defibrillator
ICD with left bundle branch area pacing (LBBAP)DEVICE

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
Group 1: Left bundle branch area pacing (LBBAP)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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;
  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meshalkin Scientific Research Center of the Ministry of Health of Russia

Novosibirsk, Novosibirsk Oblast, 630055, Russia

RECRUITING

MeSH Terms

Conditions

Cardiomyopathy, HypertrophicDeath, Sudden, CardiacHeart Failure

Interventions

Defibrillators, Implantable

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve DiseasesHeart ArrestDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DefibrillatorsElectrodesElectrical Equipment and SuppliesEquipment and SuppliesElectrodes, ImplantedProstheses and Implants

Central Study Contacts

Valentina Sergeevna Kirilova, PhD, MD

CONTACT

+79044714203kirilova_v@meshalkin.ru

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 1, 2026

First Posted

January 28, 2026

Study Start

November 14, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

January 28, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)