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

March 19, 2016 updated by: Meshalkin Research Institute of Pathology of Circulation

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
    • Novosibirsk territory
      • Novosibirsk, Novosibirsk territory, Russian Federation, 630055
        • Recruiting
        • Novosibirsk State Research Institute of Circulation Pathology
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Names:
  • myectomy
Other: 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 Names:
  • myectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The pressure gradient in the output section of the left ventricle
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The function of the mitral valve
Time Frame: one year
(Residual mitral regurgitation, SAM syndrome)
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Investigators

  • Principal Investigator: Aleksandr V Bogachev-Prokophiev, PhD, Meshalkin Research Institute of Pathology of Circulation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

July 1, 2015

First Submitted That Met QC Criteria

July 7, 2015

First Posted (Estimate)

July 8, 2015

Study Record Updates

Last Update Posted (Estimate)

March 22, 2016

Last Update Submitted That Met QC Criteria

March 19, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-435

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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