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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| alfieri technique + Septal myectomy | Experimental | Septal myectomy plus mitral valve repair using alfieri stich |
|
| Subvalvular intervention + Septal myectomy | Active Comparator | Septal myectomy plus subvalvular mitral valve intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Septal myectomy | Procedure | Transaortic septal myectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Transmitral pressure gradient | Transmitral pressure gradient after the procedures assessed by echocardiography | 30-days |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novosibirsk State Research Institute of Circulation Pathology | Novosibirsk | 630055 | Russia |
Restricted by local policy
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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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| alfieri stich | Procedure | Transaortic Mitral valve repair using alfieri technique |
|
| Subvalvular intervention | Procedure | Transaortic Mitral valve subvalvular intervention including anterior mitral leaflet secondary cord cutting, papillary muscle release |
|
| intraoperative measuerment |
| Early mortality | All cause death during 30 days | 30 days |
| D001024 |
| Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |