MedTrace Logo

Surgical Treatment of the Patients With Restrictive Phenotype of the Hypertrophic Cardiomyopathy Without LVOT Obstruction

NCT06977646 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2025-07-02

No results posted yet for this study

Summary

Hypertrophic cardiomyopathy - is an inherited disease characterized by pronounced genetic and phenotypic heterogeneity. There are two most common anatomic variants of cardiac hypertrophy: subaortic and submitral phenotypes. Subaortic phenotype is characterized by hypertrophy of the basal parts of the heart, mainly in the interventricular septum (IVS), manifesting by a high pressure gradient in the LVOT. Submitral phenotype is characterized by localization of hypertrophic zone downward to the apex and apical phenotype is without a pressure gradient in the LVOT.

The morphology, nature of hemodynamic abnormalities not well studied in patients with apical phenotype of HCM, and surgical treatment are controversial, and for those patients with advanced stage of the HF the orthotopic heart transplantations (HTx) is usually considered.

One of the surgical techniques available for this category of patients is apical myectomy. The main goal of this intervention is increasing the left ventricular volume and improving of the LV compliance with an increase of the diastolic relaxation. Limited data of such procedures in HCM patients were already published but it still requires further investigation on larger cohort of patients.

In this study, the investigators hypothesize that along with left ventricular septal hypertrophy, a small cavity is formed in patients with submittal-apical phenotype due to an increased number of hypertrophied papillary muscles. They are displaced to the apex and tightly fixed both among themselves and to the left ventricular walls. This causes a significant reduction in diastolic volume and left ventricular relaxation capacity. The present study will analyze the experience of performing resection of hypertrophied trabeculae and mobilization of papillary muscles performed through the aorta. Throw this approach procedure can be done without the need for traumatic access and suturing in the apex of the left ventricle.

Conditions

  • Apical Hypertrophic Cardiomyopathy

Interventions

PROCEDURE

Surgical transaortic left ventricular cavity remodeling in patients with apical hypertrophic cardiomyopathy without left ventricular outflow tract obstruction

The proposed intervention is a variation of classical myectomy, but unlike it, the main substrate for resection is not only the hypertrophied interventricular septum, but the abnormal papillary muscles and interpapillary trabeculae in the left ventricular cavity

Sponsors & Collaborators

  • Petrovsky National Research Centre of Surgery

    lead OTHER

Principal Investigators

  • Sergey L Dzemeshkevich, MD, PhD, Prof. · Petrovsky National Research Centre of Surgery

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2025-09-01
Completion
2025-12-01

Countries

  • Russia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06977646 on ClinicalTrials.gov