Actively Recruiting
Left Bundle Branch Pacing 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
84 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
- Patients with post-myectomy hypertrophic cardiomyopathy who develop left bundle branch block with a QRS complex greater than 130 ms and a high risk of sudden cardiac death (HCM Risk-SCD ≥ 6%)
- Signed informed consent to participate in the study
You will not qualify if you...
- Absence of QRS complex morphology consistent with left bundle branch block 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 the next 6 months
- Patients with intermediate or low risk of sudden cardiac death
- History of acute myocardial infarction less than three months prior to study inclusion
- Acute renal and hepatic failure
- Acute infectious diseases
- Presence of mental illness
- Presence of other illnesses with life expectancy less than one year
- Patient refusal to participate in the study at any stage
AI-Screening
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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
CONTACT
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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