Hypertrophic Obstructive Cardiomyopathy Clinical Trial
Official title:
Compare Results of Mitral Valve Replacement or Repair in the Surgical Treatment of Obstructive Hypertrophic Cardiomyopathy With Severe Mitral Insufficiency.
Compare the results of reconstruction and mitral valve replacement in the surgical treatment of obstructive hypertrophic cardiomyopathy with severe mitral insufficiency.
Status | Completed |
Enrollment | 82 |
Est. completion date | May 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Russian Federation | Novosibirsk State Research Institute of Circulation Pathology | Novosibirsk | Novosibirsk territory |
Lead Sponsor | Collaborator |
---|---|
Meshalkin Research Institute of Pathology of Circulation |
Russian Federation,
Surgical Treatment of Hypertrophic Obstructive Cardiomyopathy With severe Mitral regurgitation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The function of the mitral valve (mitral regurgitation return, prosthesis dysfunction) | one year | No | |
Secondary | The pressure gradient in the output section of the left ventricle | one year | No |
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