Mitral Valve Management During Septal Myectomy (MVMSM)

Meshalkin Research Institute of Pathology of Circulation

Status: Completed

Conditions: Hypertrophic Cardiomyopathy

Treatments: Procedure: Subvalvular intervention; Procedure: alfieri stich; Procedure: Septal myectomy

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT03906734

2017-01-12-3.1

Details and patient eligibility

About

Objective of the study: to evaluate whether alfieri technique improves clinical and hemodynamic results compared to transaortic mitral valve secondary cord cutting in patients scheduled to septal myectomy for severely symptomatic hypertrophic obstructive cardiomyopathy.

Full description

There is pilot prospective randomised study comparing immediate and early results of additional subvalvular mitral apparatus intervention versus additional alfieri stich in patients scheduled to septal myectomy for symptomatic obstructive cardiomyopathy.

Patients with proven hypertrophic cardiomyopathy and resting left ventricle outflow tract obstruction underwent septal myectomy. If patients were suitable for both surgical techniques, they were randomized to alfieri stich or secondary cord cutting. All surgeons were experienced at least 50 related procedures.

Enrollment: 48 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hypertrophic obstructive cardiomyopathy
• Left ventricle outflow tract gradient > 50 mm Hg at rest
• Systolic anterior motion mediated mitral regurgitation

Exclusion criteria

• Intrinsic valvular heart disease
• Coronary artery disease
• Aortic disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

alfieri technique + Septal myectomy

Experimental group

Description:

Septal myectomy plus mitral valve repair using alfieri stich

Treatment:

Procedure: Septal myectomy

Procedure: alfieri stich

Subvalvular intervention + Septal myectomy

Active Comparator group

Description:

Septal myectomy plus subvalvular mitral valve intervention

Treatment:

Procedure: Subvalvular intervention

Procedure: Septal myectomy