RecruitingNot Applicable

Left Bundle Branch Pacing in Patients With Hypertrophic Cardiomyopathy After Myectomy

Russia30 participantsStarted 2025-11-14

Plain-language 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. 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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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;

What they're measuring

Serious Adverse Events

Timeframe: 48 hours

Efficiency

Timeframe: 3-6-12 month

Trial details

NCT IDNCT07372196

SponsorMeshalkin Research Institute of Pathology of Circulation

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2027-05-01

Contact for this trial

Valentina Sergeevna Kirilova, PhD, MD

+79044714203 kirilova_v@meshalkin.ru