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Clinical Trials/NCT02054221
NCT02054221
Completed
Not Applicable

Compare Results of Mitral Valve Replacement or Repair in the Surgical Treatment of Obstructive Hypertrophic Cardiomyopathy With Severe Mitral Insufficiency.

Meshalkin Research Institute of Pathology of Circulation1 site in 1 country82 target enrollmentOctober 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertrophic Obstructive Cardiomyopathy
Sponsor
Meshalkin Research Institute of Pathology of Circulation
Enrollment
82
Locations
1
Primary Endpoint
The function of the mitral valve (mitral regurgitation return, prosthesis dysfunction)
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
October 2013
End Date
May 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Meshalkin Research Institute of Pathology of Circulation
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

The function of the mitral valve (mitral regurgitation return, prosthesis dysfunction)

Time Frame: one year

Secondary Outcomes

  • The pressure gradient in the output section of the left ventricle(one year)

Study Sites (1)

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