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

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ClinicalTrials.gov Identifier: NCT02492399
Recruitment Status : Unknown
Verified March 2016 by Meshalkin Research Institute of Pathology of Circulation.
Recruitment status was:  Recruiting
First Posted : July 8, 2015
Last Update Posted : March 22, 2016
Sponsor:
Information provided by (Responsible Party):
Meshalkin Research Institute of Pathology of Circulation

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.

Condition or disease Intervention/treatment Phase
Hypertrophic Obstructive Cardiomyopathy Procedure: extended myectomy Procedure: myectomy by Morrow Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Compare the Results for the Extended Myoectomy and Standard Morrow's Myoectomy in Patients With Ventricular Obstruction of the Left Ventricular Output
Study Start Date : January 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017


Arm Intervention/treatment
myectomy by Morrow

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
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.
Other Name: myectomy

extended myectomy

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
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.
Other Name: myectomy




Primary Outcome Measures :
  1. The pressure gradient in the output section of the left ventricle [ Time Frame: one year ]

Secondary Outcome Measures :
  1. The function of the mitral valve [ Time Frame: one year ]
    (Residual mitral regurgitation, SAM syndrome)



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02492399


Locations
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Russian Federation
Novosibirsk State Research Institute of Circulation Pathology Recruiting
Novosibirsk, Novosibirsk territory, Russian Federation, 630055
Contact: Alexander V Bogachev-Prokophiev, PhD    +79137539546    bogachev.prokophiev@gmail.com   
Contact: Michael S Fomenko    +79612183098    enimol36@gmail.com   
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation
Investigators
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Principal Investigator: Aleksandr V Bogachev-Prokophiev, PhD Meshalkin Research Institute of Pathology of Circulation
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Responsible Party: Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT02492399    
Other Study ID Numbers: 12-435
First Posted: July 8, 2015    Key Record Dates
Last Update Posted: March 22, 2016
Last Verified: March 2016
Keywords provided by Meshalkin Research Institute of Pathology of Circulation:
hypertrophic cardiomyopathy
mitral valve
SAM syndrome
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Hypertrophic
Hypertrophy
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Aortic Valve Disease
Heart Valve Diseases