Surgical Treatment of Hypertrophic Obstructive Cardiomyopathy With Severe Mitral Insufficiency.

Not Applicable

Completed

• Conditions: Hypertrophic Obstructive Cardiomyopathy
• Interventions: Procedure: myoectomy; Procedure: Mitral valve surgery

• Registration Number: NCT02054221
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-12-27
• Study First Submitted QC: 2014-02-03
• Study First Posted: 2014-02-04
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-01
• Last Update Posted: 2015-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
extended myectomy + MVreplacement	myoectomy	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.
extended myectomy + MVrepair	Mitral valve surgery	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 .
extended myectomy + MVreplacement	Mitral valve surgery	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.
extended myectomy + MVrepair	myoectomy	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 .

Primary Outcome Measures

Name	Time	Method
The function of the mitral valve (mitral regurgitation return, prosthesis dysfunction)	one year

Secondary Outcome Measures

Name	Time	Method
The pressure gradient in the output section of the left ventricle	one year

Trial Locations

Locations (1)

Novosibirsk State Research Institute of Circulation Pathology; 🇷🇺 Novosibirsk, Novosibirsk territory, Russian Federation