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Surgical Treatment of Hypertrophic Obstructive Cardiomyopathy With Severe Mitral Insufficiency.

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ClinicalTrials.gov Identifier: NCT02054221
Recruitment Status : Completed
First Posted : February 4, 2014
Last Update Posted : July 2, 2015
Sponsor:
Information provided by (Responsible Party):
Meshalkin Research Institute of Pathology of Circulation

Brief Summary:
Compare the results of reconstruction and mitral valve replacement in the surgical treatment of obstructive hypertrophic cardiomyopathy with severe mitral insufficiency.

Condition or disease Intervention/treatment Phase
Hypertrophic Obstructive Cardiomyopathy Procedure: myoectomy Procedure: Mitral valve surgery 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. But the question remains what is best for patients with obstructive hypertrophic cardiomyopathy and severe mitral insufficiency: use extended myoectomy with mitral valve repair a or replacement.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Compare Results of Mitral Valve Replacement or Repair in the Surgical Treatment of Obstructive Hypertrophic Cardiomyopathy With Severe Mitral Insufficiency.
Study Start Date : October 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015


Arm Intervention/treatment
extended myectomy + MVreplacement

Procedure: extended myoectomy, mitral valve surgery

Will be included in a group of 41 patients with obstructive hypertrophic cardiomyopathy and severe mitral insufficiency. Intraoperatively for all patients will be executed TEE to calculate the volume of excision. All patients will be performed extended myoectomy with full isscheniem subvalvular apparatus and mitral valve replacement.

Evaluation results will be made myoectomy as TEE and direct tensiometer.

Procedure: myoectomy
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: Extended myoectomy

Procedure: Mitral valve surgery
41 patients will be performed mitral valve replacement with complete excision of the subvalvular apparatus.
Other Name: mitral valve replacement

extended myectomy + MVrepair

Procedure: extended myoectomy, mitral valve surgery

Will be included in a group of 41 patients with obstructive hypertrophic cardiomyopathy and severe 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 and the mitral valve repair. Results of mitral valve repair will be more appreciated intraoperatively. In case of unsatisfactory MV repair will reconnect the device artificial circulation and mitral valve replacement. There after, patients will be moved to the first group.

Evaluation results will be made myoectomy as TEE and direct tensiometer .

Procedure: myoectomy
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: Extended myoectomy

Procedure: Mitral valve surgery
41 patients will be performed mitral valve repair. Results of mitral valve repair will be more appreciated intraoperatively. In case of unsatisfactory MV repair will reconnect the device artificial circulation and mitral valve replacement. There after, patients will be moved to the first group.
Other Name: mitral valve repair




Primary Outcome Measures :
  1. The function of the mitral valve (mitral regurgitation return, prosthesis dysfunction) [ Time Frame: one year ]

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


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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
  • surgically significant mitral insufficiency
  • 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): NCT02054221


Locations
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Russian Federation
Novosibirsk State Research Institute of Circulation Pathology
Novosibirsk, Novosibirsk territory, Russian Federation, 630055
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

Publications:
Surgical Treatment of Hypertrophic Obstructive Cardiomyopathy With severe Mitral regurgitation

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT02054221     History of Changes
Other Study ID Numbers: HOCM - 95
1957 ( Other Identifier: NRICP )
First Posted: February 4, 2014    Key Record Dates
Last Update Posted: July 2, 2015
Last Verified: July 2015
Keywords provided by Meshalkin Research Institute of Pathology of Circulation:
hypertrophic cardiomyopathy
mitral valve
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Hypertrophic
Mitral Valve Insufficiency
Hypertrophy
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases