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Study of Aortic Root Reimplantation Procedure

NCT ID: NCT01787604

Last Updated: 2019-06-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2015-11-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ascending Aortic Aneurism Aortic Valve Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Aortic Root Reimplantation Procedure

Aortic Root Reimplantation Procedure

Group Type ACTIVE_COMPARATOR

Aortic Root Reimplantation Procedure

Intervention Type PROCEDURE

Modified Florida Sleeve.

Aortic Valve Reimplantation Procedure

Aortic Valve Reimplantation Procedure

Group Type ACTIVE_COMPARATOR

Aortic Valve Reimplantation Procedure

Intervention Type PROCEDURE

David I

Interventions

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Aortic Root Reimplantation Procedure

Modified Florida Sleeve.

Intervention Type PROCEDURE

Aortic Valve Reimplantation Procedure

David I

Intervention Type PROCEDURE

Other Intervention Names

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Modified Florida Sleeve. David I

Eligibility Criteria

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Inclusion Criteria

* Aortic insufficiency 2+
* Ascending aorta or aortic root of greater than 4.5 cm (\> 4.0 cm in Marfan syndrome)
* Good conditions of aortic cusps

Exclusion Criteria

* Aortic annulus more than 32 mm
* Aortic cusps destruction
* Critical aortic cusps elongation
* Aortic root dissection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meshalkin Research Institute of Pathology of Circulation

NETWORK

Sponsor Role lead

Responsible Party

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Dmitry Khvan

cardiac surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Meshalkin State Research Institute of Circulation Pathology

Novosibirsk, , Russia

Site Status

Countries

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Russia

References

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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

Reference Type 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

Reference Type RESULT

Other Identifiers

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STAR

Identifier Type: -

Identifier Source: org_study_id

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