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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| isolated septal myectomy | Other | Isolated extended septal myectomy |
|
| Septal myectomy+ "edge-to-edge" | Active Comparator | advanced septal myectomy in combination with mitral valve repair using the edge-to-edge technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mitral valve repair by edge-to-edge technique | Procedure | transaortic access for mitral valve repair edge-to-edge |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexander V. Bogachev-Prokophiev, MD, PhD | Contact | +73833476029 | bogachev.prokophiev@gmail.com | |
| Sergei A. Budagaev | Contact | +73833476029 | ser.bud.med@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Alexander V. Bogachev-Prokophiev, MD, PhD | E.Meshalkin National medical research center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "E.Meshalkin National medical research center" of the Ministry of Health of the Russian Federation | Recruiting | Novosibirsk | Russia |
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| ID | Term |
|---|---|
| D002312 | Cardiomyopathy, Hypertrophic |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001020 | Aortic Stenosis, Subvalvular |
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A randomized clinical trial comparing mitral valve repair using the edge-to-edge technique for surgical treatment of hypertrophic cardiomyopathy
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no data
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| Septal myectomy | Procedure | isolated extended septal myectomy |
|
|
| D001024 |
| Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |