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Left Bundle Branch Pacing in Patients With Hypertrophic Cardiomyopathy After Myectomy

RecruitingNAAges 18 Years - 75 YearsAllMeshalkin Research Institute of Pathology of Circ…
NCT07372196 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 compa

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📋 Eligibility rules (as published)
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;
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What it tests

  • ICD with left bundle branch area pacing (LBBAP)
  • dual-chamber ICD
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Where

1 site
Meshalkin Scientific Research Center of the Ministry of Health of Russia
Novosibirsk, Russia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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