Study of Aortic Root Reimplantation Procedure (STAR)
March 10, 2019 updated by: Dmitry Khvan, Meshalkin Research Institute of Pathology of Circulation
Superiority Trial of Aortic Root Reimplantation Procedure Versus Aortic Valve Reimplantation Procedure
Authors hypothesize that aortic root reimplantation procedure is superior over standard aortic valve reimplantation procedure in the incidence of aortic valve replacement.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Novosibirsk, Russian Federation, 630055
- Meshalkin State Research Institute of Circulation Pathology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Aortic Root Reimplantation Procedure
|
Modified Florida Sleeve.
Other Names:
|
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Active Comparator: Aortic Valve Reimplantation Procedure
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David I
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Freedom From Aortic Insufficiency More Than 2+ (Percentage, Kaplan-Meier)
Time Frame: up to 4 yeras
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Survival (Percentage, Kaplan-Meier)
Time Frame: up to 4 yeras
|
Estimated percentage of alive participants for 4 years after treatment.
|
up to 4 yeras
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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
- 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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2011
Primary Completion (Actual)
November 20, 2015
Study Completion (Actual)
November 20, 2015
Study Registration Dates
First Submitted
January 30, 2013
First Submitted That Met QC Criteria
February 6, 2013
First Posted (Estimate)
February 8, 2013
Study Record Updates
Last Update Posted (Actual)
June 10, 2019
Last Update Submitted That Met QC Criteria
March 10, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STAR
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