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Enrolling By InvitationNCT06977646

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

Retrospective Study of the Surgical Treatment Restrictive Form of the Hypertrophic Cardiomyopathy Without of the Left Ventricular Outflow Tract Obstruction

Status
Enrolling By Invitation
Phase
Study type
Observational
Enrollment
50 (estimated)
Sponsor
Petrovsky National Research Centre of Surgery · Academic / Other
Sex
All
Age
15 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDURESurgical transaortic left ventricular cavity remodeling in patients with apical hypertrophic cardiomyopathy without left ventricular outflow tract obstructionThe 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

Timeline

Start date
2025-06-01
Primary completion
2025-09-01
Completion
2025-12-01
First posted
2025-05-18
Last updated
2025-07-02

Locations

1 site across 1 country: Russia

Source: ClinicalTrials.gov record NCT06977646. Inclusion in this directory is not an endorsement.