Mitral Valve Management During Septal Myectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Alfieri Stich Versus Secondary Cord Cutting During Septal Myectomy in Patients With Hypertrophic Obstructive Cardiomyopathy: A Pilot Randomized Trial

Conditions
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Hypertrophic Cardiomyopathy

Intervention / Treatment
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* Procedure: Septal myectomy
* Procedure: alfieri stich
* Procedure: Subvalvular intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: alfieri technique + Septal myectomy<br>Septal myectomy plus mitral valve repair using alfieri stich | Procedure: Septal myectomy<br>* Transaortic septal myectomy<br>Procedure: alfieri stich<br>* Transaortic Mitral valve repair using alfieri technique<br>|
| Active Comparator: Subvalvular intervention + Septal myectomy<br>Septal myectomy plus subvalvular mitral valve intervention | Procedure: Septal myectomy<br>* Transaortic septal myectomy<br>Procedure: Subvalvular intervention<br>* Transaortic Mitral valve subvalvular intervention including anterior mitral leaflet secondary cord cutting, papillary muscle release<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transmitral pressure gradient | Transmitral pressure gradient after the procedures assessed by echocardiography | 30-days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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septal myectomy, hypertrophic cardiomyopathy