Edge-to-edge Mitral Valve Repair in the Surgical Treatment for Hypertrophic Cardiomyopathy

Study Overview
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Brief Summary
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Objective of the study: to evaluate whether edge-to-edge technique improves clinical and hemodynamic results in patients scheduled to septal myectomy for severely symptomatic hypertrophic obstructive cardiomyopathy.

Detailed Description
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A randomised controlled pilot trial to evaluate whether edge-to-edge technique improves clinical and hemodynamic results in patients scheduled to septal myectomy for severely symptomatic hypertrophic 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 septal myectomy + edge-to-edge mitral valve repair or isolated septal myectomy. All surgeons were experienced at least 50 related procedures.

Official Title
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A Randomised Controlled Pilot Trial: Edge-to-edge Mitral Valve Repair in the Surgical Treatment for Hypertrophic Cardiomyopathy

Conditions
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Hypertrophic Obstructive Cardiomyopathy

Intervention / Treatment
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* Procedure: mitral valve repair by edge-to-edge technique
* Procedure: Septal myectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide written informed consent (either from the patient or a substitute decision-maker) Indications for surgical treatment (septal myectomy) of hypertrophic cardiomyopathy Exclusion Criteria: indications for mitral valve replacement Patient failure at any stage of the study

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
Interventional Model Description: A randomized clinical trial comparing mitral valve repair using the edge-to-edge technique for surgical treatment of hypertrophic cardiomyopathy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: isolated septal myectomy<br>Isolated extended septal myectomy | Procedure: Septal myectomy<br>* isolated extended septal myectomy<br>* Other names: Septal myectomy (SM);|
| Active Comparator: Septal myectomy+ edge-to-edge<br>advanced septal myectomy in combination with mitral valve repair using the edge-to-edge technique | Procedure: mitral valve repair by edge-to-edge technique<br>* transaortic access for mitral valve repair edge-to-edge<br>* Other names: Alfieri stitch;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left Ventricular Outflow Tract (LVOT) gradient | Gradient at the level of the output section of the left ventricle after surgery (mmHg) This measurement will be performed by transthoracic echocardiography at rest and / or during exercise. The Doppler method will be used. | 12 months in the medium-term follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic anterior motion of the mitral valve | Systolic anterior motion of the mitral valve after surgery This measurement will be performed by transthoracic echocardiography at rest and / or during exercise. | 12 months in the medium-term follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Septal myectomy, edge-to-edge repair, mitral valve plastic (MVP)