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Comparisonof Extended Myoectomy and Myoectomy by Morrow in Patients With Hypertrophic Obstructive Cardiomyopathy (HOCM)

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02492399
Enrollment
60
Registered
2015-07-08
Start date
2014-01-31
Completion date
2017-12-31
Last updated
2016-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertrophic Obstructive Cardiomyopathy

Keywords

hypertrophic cardiomyopathy, mitral valve, SAM syndrome

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.

Interventions

PROCEDUREextended myectomy

The scheme of extended septal myectomy: Two parallel incisions were made into the septal bulge and connected to remove the muscle mass. Myectomy was extended to the base of the papillary muscles, when midseptal thickening was present. The papillary muscles were grasped and pushed medially to visualize the abnormal connections between the papillary muscles and the anterior wall of the ventricle. A blade was used to divide the thickened abnormal attachments. A pituitary rongeur may be used to resect a portion of the junction of the papillary and lateral wall. This reduces the diameter of the papillary muscle and allows for posterior displacement of the anterior mitral leaflet. Division of abnormal attachments and thinning of the papillary muscles is critical for the treatment of SAM.

PROCEDUREmyectomy by Morrow

A first myotomy is made into the septum just below the base of the right coronary leaflet at a point 2-3 mm to the right of the commissure between the left and right coronary leaflets. A second myotomy is made in the same manner, parallel to the first one and about 1 cm to the right of it. The two vertical myotomies are made and cornnected transversely in the interventricular septum. The muscle bar is then grasped with the angled rongeur and the instrument is pushed firmly toward the apex, peeling the mtusele from its anterior septal attachments. After completion of the resectioni, a rectangular channel about 1 X 1.5 cm is palpable from the valve ring toward the apex for a dis- tance of about 4 cm.

Sponsors

Meshalkin Research Institute of Pathology of Circulation
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The pressure gradient in the output section of the left ventricleone year

Secondary

MeasureTime frameDescription
The function of the mitral valveone year(Residual mitral regurgitation, SAM syndrome)

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026