Clinical trial NCT01787604: Study of Aortic Root Reimplantation Procedure
Official title: Superiority Trial of Aortic Root Reimplantation Procedure Versus Aortic Valve Reimplantation Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ascending Aortic Aneurism
Aortic Valve Insufficiency
Keywords: Valve-sparing
Valve repair
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2013-02-08
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Authors hypothesize that aortic root reimplantation procedure is superior over standard aortic valve reimplantation procedure in the incidence of aortic valve replacement.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Freedom From Aortic Insufficiency More Than 2+ (Percentage, Kaplan-Meier)
timeFrame: up to 4 yeras
Secondary outcomes:
measure: Survival (Percentage, Kaplan-Meier)
timeFrame: up to 4 yeras
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Meshalkin State Research Institute of Circulation Pathology
Study officials:
References:
citation: 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
citation: 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