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Clinical Trials/NCT02492399
NCT02492399
Unknown
Not Applicable

Compare the Results for the Extended Myoectomy and Standard Morrow's Myoectomy in Patients With Ventricular Obstruction of the Left Ventricular Output

Meshalkin Research Institute of Pathology of Circulation1 site in 1 country60 target enrollmentJanuary 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertrophic Obstructive Cardiomyopathy
Sponsor
Meshalkin Research Institute of Pathology of Circulation
Enrollment
60
Locations
1
Primary Endpoint
The pressure gradient in the output section of the left ventricle
Last Updated
10 years ago

Overview

Brief Summary

The purpose of this study is to determine whether the application of the extended myoectomy in patients with obstruction of the left ventricular output more efficient than standard myoectomy by Morrow.

Detailed Description

Many years myoectomy for Morrow was the gold standard in the treatment of obstructive hypertrophic cardiomyopathy. Currently more retrospective data in the literature about the good results the extended septal myectomy. Use of extended myomectomy eliminates mitral insufficiency due to SAM syndrome. The question remains whether it is possible at hypertrophic cardiomyopathy basal part and mediated mitral insufficiency use only myoectomy by Morrow is achieved regression SAM syndrome and release output of the left ventricle. Planned to create two equal groups of 30 people that will use two methods of surgical treatment of obstructive hypertrophic cardiomyopathy. The study will be terminated in the event of complete AV block more than 2% and unsatisfactory results of a myoectomy requiring perform mitral valve replacement in more than 15% of the patients studied. The study assumed crossover: in case of failure elimination SAM syndrome and mediated mitral insufficiency myoectomy by Morrow for patients will perform extended myoectomy in the case of a good result in patients are moved to the second group. Planned studies the long-term and immediate results of operations: * Quantitative determination of enzymes of myocardial injury: creatine phosphokinase MB and troponin I. * Determination of atrial natriuretic peptide (ANP) and brain natriuretic peptide (VNP). * MRI with contrast heart to assess remodeling of the heart chambers and heart weight measurements. * TEE evaluation function and mitral valve gradient at the output of the left ventricle.

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
December 2017
Last Updated
10 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Meshalkin Research Institute of Pathology of Circulation
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Able to sign Informed Consent and Release of Medical Information forms
  • Age ≥ 18 years
  • obstructive hypertrophic cardiomyopathy
  • mediated mitral insufficiency by SAM syndrome
  • II-IV (NYHA),
  • average systolic pressure gradient greater than 50 mm Hg. Art. at rest;
  • basal or medium ventricular obstruction

Exclusion Criteria

  • Related defect of the aortic valve;
  • Organic mitral valve disease (dysplasia, rheumatic fever, infective endocarditis);
  • Surgically significant coronary artery lesions;
  • Patients requiring implantation of a cardioverter-defibrillator

Outcomes

Primary Outcomes

The pressure gradient in the output section of the left ventricle

Time Frame: one year

Secondary Outcomes

  • The function of the mitral valve(one year)

Study Sites (1)

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