Left bundle branch pacing plus ICD for people with hypertrophic cardiomyopathy after myectomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with HCM who develop true left bundle branch block after surgical myectomy and are at high risk of sudden cardiac death are randomized 1:1 to receive either a standard dual‑chamber ICD or a dual‑chamber ICD with left bundle branch area pacing. The pilot trial plans to enroll 30 patients (15 per group) and compares procedural safety, ECG measures (QRS duration, LV activation time), pacing thresholds, biomarkers, imaging and patient‑reported outcomes including KCCQ‑12. Follow‑up includes intraoperative, hospitalization and outpatient assessments to detect implantation complications, changes in electrical conduction, and left ventricular remodeling. The protocol also aims to standardize a technique for LBB lead implantation in this HCM population.

Why it matters

Who can join: the full rules

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;

Where it's running

• Meshalkin Scientific Research Center of the Ministry of Health of Russia
  Novosibirsk, Novosibirsk Oblast, Russia Recruiting

Study contacts

• Study coordinator: Valentina Sergeevna Kirilova, PhD, MD
• Email: kirilova_v@meshalkin.ru
• Phone: +79044714203

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.