Surgical Treatment of Hypertrophic Obstructive Cardiomyopathy With Severe Mitral Insufficiency.

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02054221
• Other study ID #: HOCM - 95
• Secondary ID: 1957
• Status: Completed
• Phase: N/A
• First received: December 27, 2013
• Last updated: July 1, 2015
• Start date: October 2013
• Est. completion date: May 2015

Study information

• Verified date: July 2015
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophic Obstructive Cardiomyopathy
• Hypertrophy
• Mitral Valve Insufficiency

Intervention

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.
• Mitral valve surgery
41 patients will be performed mitral valve replacement with complete excision of the subvalvular apparatus.
• 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.

Locations

Country	Name	City	State
Russian Federation	Novosibirsk State Research Institute of Circulation Pathology	Novosibirsk	Novosibirsk territory

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

References & Publications (1)

Surgical Treatment of Hypertrophic Obstructive Cardiomyopathy With severe Mitral regurgitation

Outcome

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