Actively Recruiting
Left Bundle Branch Pacing Versus Dual-Chamber Cardioverter-Defibrillator Implantation in Patients With Hypertrophic Cardiomyopathy After Myectomy
Led by Meshalkin Research Institute of Pathology of Circulation · Updated on 2026-01-28
30
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of left bundle branch pacing (LBBP) in patients with hypertrophic cardiomyopathy (HCM) who have undergone myectomy surgery and have complete left bundle branch block (LBBB). The study aims to compare the outcomes of implanting a cardioverter-defibrillator (ICD) with LBB pacing versus a traditional dual-chamber ICD in patients at high risk of sudden cardiac death (SCD). This pilot randomized trial will analyze various heart function measures, arrhythmia occurrences, and quality of life over time. Participants are randomly divided into two groups: one receiving a dual-chamber ICD with LBB pacing and the other receiving a standard dual-chamber ICD. The LBB pacing procedure involves implanting electrodes into the interventricular septum near the His bundle to alter heart electrical activation, while the traditional ICD implantation follows standard pacemaker placement techniques. Both groups will undergo ICD programming and assessment at 3, 6, and 12 months after surgery. During the study, researchers will collect demographic and clinical data, including heart function tests, ECG measurements, blood markers like NT-proBNP, and quality of life questionnaires before surgery and 12 months afterward. They will monitor ICD function, complications, heart rhythm episodes, and heart remodeling through echocardiography and ECG at multiple follow-up visits. The study duration includes initial hospitalization and one year of monitoring to evaluate outcomes and safety.
CONDITIONS
Brief Title
Left Bundle Branch Pacing in Patients With Hypertrophic Cardiomyopathy After Myectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 years and older
- Diagnosed with hypertrophic cardiomyopathy after myectomy surgery
- Complete left bundle branch block with a QRS complex greater than 130 ms
- High risk of sudden cardiac death (6% or higher) based on HCM Risk-SCD
- Signed informed consent to participate in the study
You will not qualify if you...
- Absence of left bundle branch block morphology or QRS complex less than 130 ms
- Presence of baseline complete right bundle branch block
- Planned heart transplantation or left ventricular assist device implantation within 6 months
- Intermediate or low risk of sudden cardiac death
- Heart attack within 3 months prior to study inclusion
- Acute renal or hepatic failure
- Acute infectious diseases
- Presence of mental illness
- Other illnesses with life expectancy less than one year
- Patient refusal to participate at any stage
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of implantation
Participants will undergo implantation of either a dual-chamber cardioverter-defibrillator with left bundle branch area pacing or a dual-chamber cardioverter-defibrillator without pacing.
1 procedural visit (in-person)
Duration - Up to several days after implantation
Participants are monitored for complications related to the device implantation procedure and adequate device function during hospitalization.
Approximately 1 hospital stay with monitoring
Duration - Up to 12 months after implantation
Participants will be assessed periodically to evaluate device efficiency, heart function, quality of life, and adverse events.
Follow-up visits at 3, 6, and 12 months (in-person)
Trial Site Locations
Total: 1 location
1
Meshalkin Scientific Research Center of the Ministry of Health of Russia
Novosibirsk, Novosibirsk Oblast, Russia, 630055
Actively Recruiting
Research Team
V
Valentina Sergeevna Kirilova, PhD, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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