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

NCT02492399 | Unknown

• 1 other identifier: 12-435
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertrophic Obstructive Cardiomyopathy

Keywords

hypertrophic cardiomyopathy; mitral valve; SAM syndrome

Outcome Measures

Primary Outcomes (1)

• The pressure gradient in the output section of the left ventricle

  one year

Secondary Outcomes (1)

• The function of the mitral valve

  one year

Study Arms (2)

myectomy by Morrow

OTHER

Procedure: myectomy by Morrow. Will be included in a group of 30 patients with obstructive hypertrophic cardiomyopathy and mitral insufficiency. In the case of conservation SAM syndrome and mediated mitral insufficiency, the result will be read as unsatisfactory. Patients will perform advanced myoectomy. All patients who need to be supplemented by the operation extension myoectomy subsequently run out in the second group. When it is impossible to eliminate mediated mitral regurgitation without mitral valve replacement, patients performed myoectomy and mitral valve replacement. The result in this case is read as completely unsatisfactory. Upon reaching 15% replacement mitral valve study terminated. Evaluation results will be made myoectomy as TEE and direct tensiometer.

Procedure: myectomy by Morrow

extended myectomy

OTHER

Procedure: extended myectomy. Will be included in a group of 30 patients with obstructive hypertrophic cardiomyopathy and mitral insufficiency. Intraoperatively for all patients will be executed TEE to calculate the volume of excision. All patients will be performed extended myoectomy which supplemented resection and release of the papillary muscles. In case of unsatisfactory MV repair will reconnect the device artificial circulation and mitral valve replacement. The result in this case will become engrossed in reading as completely unsatisfactory. At achievement of 15% prosthetics of the mitralny valve research stops. Evaluation results will be made myoectomy as TEE and direct tensiometer .

Procedure: extended myectomy

Interventions

extended myectomy PROCEDURE

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.

Also known as: myectomy

extended myectomy

myectomy by Morrow PROCEDURE

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.

Also known as: myectomy

myectomy by Morrow

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Meshalkin Research Institute of Pathology of Circulation: lead

Study Sites (1)

Novosibirsk State Research Institute of Circulation Pathology

Novosibirsk, Novosibirsk Territory, 630055, Russia

RECRUITING

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Officials

• Aleksandr V Bogachev-Prokophiev, PhD

  Meshalkin Research Institute of Pathology of Circulation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2015
• First Posted: July 8, 2015
• Study Start: January 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 22, 2016

Record last verified: 2016-03

Locations

RU (1)