Surgical Treatment of Hypertrophic Obstructive Cardiomyopathy With Severe Mitral Insufficiency.

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02054221

Enrollment

Registered

2014-02-04

Start date

2013-10-31

Completion date

2015-05-31

Last updated

2015-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertrophic Obstructive Cardiomyopathy

Keywords

hypertrophic cardiomyopathy, mitral valve

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.

Interventions

PROCEDUREmyoectomy

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.

PROCEDUREMitral valve surgery

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
The pressure gradient in the output section of the left ventricle	one year

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026