Mitral Valve Management During Septal Myectomy

Not Applicable

Completed

• Conditions: Hypertrophic Cardiomyopathy
• Interventions: Procedure: Septal myectomy; Procedure: alfieri stich; Procedure: Subvalvular intervention

• Registration Number: NCT03906734
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2016-01-10
• Primary Completion: 2016-10-28
• Study First Submitted: 2019-01-20
• Study Completion: 2019-03-20
• Status Verified: 2019-04
• Study First Submitted QC: 2019-04-05
• Last Update Submitted: 2019-04-05
• Study First Posted: 2019-04-08
• Last Update Posted: 2019-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
alfieri technique + Septal myectomy	alfieri stich	Septal myectomy plus mitral valve repair using alfieri stich
alfieri technique + Septal myectomy	Septal myectomy	Septal myectomy plus mitral valve repair using alfieri stich
Subvalvular intervention + Septal myectomy	Septal myectomy	Septal myectomy plus subvalvular mitral valve intervention
Subvalvular intervention + Septal myectomy	Subvalvular intervention	Septal myectomy plus subvalvular mitral valve intervention

Primary Outcome Measures

Name	Time	Method
Transmitral pressure gradient	30-days	Transmitral pressure gradient after the procedures assessed by echocardiography

Secondary Outcome Measures

Name	Time	Method
Residual left ventricle outflow tract gradient	intraoperative measuerment	Residual left ventricle outflow tract gradient assessed by direct measurement
Early mortality	30 days	All cause death during 30 days
Repeat bypass	30 day	Rate of second cross clamping and repeating bypass for procedure related reasons

Trial Locations

Locations (1)

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