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

Left Bundle Branch Pacing in Patients With Hypertrophic Cardiomyopathy After Myectomy

This study will test whether adding left bundle branch pacing to a dual‑chamber ICD helps people with hypertrophic cardiomyopathy who develop left bundle branch block after myectomy to slow heart failure progression and prevent life‑threatening arrhythmias.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Meshalkin Research Institute of Pathology of Circulation (Research network)
• Locations: 1 site (Novosibirsk, Novosibirsk Oblast)
• Trial ID: NCT07372196 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (18+) with hypertrophic cardiomyopathy who have undergone myectomy, have true LBBB with QRS >130 ms, an HCM Risk‑SCD ≥6%, and are candidates for ICD implantation who consent to participate.

Not a fit: Patients without true LBBB or with QRS <130 ms, those at intermediate or low SCD risk, those planning transplant or LVAD within six months, recent MI, acute organ failure, limited life expectancy (<1 year), or who decline participation are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, adding LBB pacing could improve electrical synchrony, promote reverse left ventricular remodeling, slow heart failure progression and reduce life‑threatening arrhythmias in this high‑risk group.

How similar studies have performed: Left bundle branch pacing has shown encouraging early results in conduction disease and some heart failure groups, but its application specifically after myectomy in HCM is novel and not proven in large randomized trials.

Eligibility criteria

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 this trial is running

Novosibirsk, Novosibirsk Oblast

• 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

Conditions HCM - Hypertrophic Cardiomyopathy; Sudden Cardiac Death; Left Bundle Branch Pacing; ICD; Heart Failure; sudden cardiac death; Hypertrophic Cardiomyopathy; Heart failure