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Authors hypothesize that aortic root reimplantation procedure is superior over standard aortic valve reimplantation procedure in the incidence of aortic valve replacement.
A single blind prospective randomized superiority study is conducted. Our hypothesis is that there is difference in the incidence of aortic valve replacement between the standard aortic valve reimplantation procedure and aortic root reimplantation procedure more than 21.1%. If there is truly difference between groups (Aortic Root Reimplantation Procedure and Aortic Valve Reimplantation Procedure), then total 64 patients for both groups are required to be 80% sure that the upper limit of a one-sided 95% confidence interval would reveal a difference in favour of the Aortic Root Reimplantation Procedure of 21.1%. The blinding process is applied to a patient, who is informed about received valve-sparing operation, but don't know the type of the last. The study was approved by Institutional Review Board. Depending on a type of the procedure, the patients are divided into two groups: Aortic Root Reimplantation Procedure group includes 32 patients and Aortic Valve Reimplantation Procedure group consists of 32 patients. Randomization is conducted intraoperatively by using accidental sampling after examining the aortic valve and making a decision on the possibility of a valve-sparing operation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aortic Root Reimplantation Procedure | Active Comparator | Aortic Root Reimplantation Procedure |
|
| Aortic Valve Reimplantation Procedure | Active Comparator | Aortic Valve Reimplantation Procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aortic Root Reimplantation Procedure | Procedure | Modified Florida Sleeve. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom From Aortic Insufficiency More Than 2+ (Percentage, Kaplan-Meier) | Estimated percentage of participants free from aortic insufficiency (AI) more than 2+ measured by echocardiography for a 4 years after treatment.. | up to 4 yeras |
| Measure | Description | Time Frame |
|---|---|---|
| Survival (Percentage, Kaplan-Meier) | Estimated percentage of alive participants for 4 years after treatment. | up to 4 yeras |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meshalkin State Research Institute of Circulation Pathology | Novosibirsk | 630055 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Alexander Chernyavskiy, Sergey Alsov, Dmitry Khvan, Dmitry Sirota. Extravalvular exoprosthetic repair of aortic root: first experience. Kardiochirurgia i Torakochirurgia Polska 2012; 9 (4): 409-414 DOI: 10.5114/kitp.2012.32675 | ||
| Result | Чернявский А. М., Хван Д. С., Альсов С. А., Сирота Д. А., Ляшенко М. М. Результаты реимплантации корня аорты в протез у пациентов с аневризмой восходящего отдела аорты и недостаточностью аортального клапана. Патология кровообращения и кардиохирургия. 2015;19(4):38-47. http://dx.doi.org/10.21688/1681-3472-2015-4-38-47 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Aortic Root Reimplantation Procedure | Aortic Root Reimplantation Procedure Aortic Root Reimplantation Procedure: Modified Florida Sleeve. |
| FG001 | Aortic Valve Reimplantation Procedure | Aortic Valve Reimplantation Procedure Aortic Valve Reimplantation Procedure: David I |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aortic Root Reimplantation Procedure | Aortic Root Reimplantation Procedure Aortic Root Reimplantation Procedure: Modified Florida Sleeve. |
| BG001 | Aortic Valve Reimplantation Procedure |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Freedom From Aortic Insufficiency More Than 2+ (Percentage, Kaplan-Meier) | Estimated percentage of participants free from aortic insufficiency (AI) more than 2+ measured by echocardiography for a 4 years after treatment.. | Posted | Number | percentage of participants | up to 4 yeras |
|
up to 4 yeras
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aortic Root Reimplantation Procedure | Aortic Root Reimplantation Procedure Aortic Root Reimplantation Procedure: Modified Florida Sleeve. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dmitry | MeshalkinRI | +79069090505 | dmhvan@mail.ru |
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| ID | Term |
|---|---|
| D001022 | Aortic Valve Insufficiency |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Aortic Valve Reimplantation Procedure | Procedure | David I |
|
|
Aortic Valve Reimplantation Procedure
Aortic Valve Reimplantation Procedure: David I
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Survival (Percentage, Kaplan-Meier) | Estimated percentage of alive participants for 4 years after treatment. | Posted | Number | percentage of participants | up to 4 yeras |
|
|
|
| 4 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Aortic Valve Reimplantation Procedure | Aortic Valve Reimplantation Procedure Aortic Valve Reimplantation Procedure: David I | 4 | 32 | 0 | 32 | 0 | 32 |
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