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Study of Aortic Root Reimplantation Procedure (STAR)

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ClinicalTrials.gov Identifier: NCT01787604
Recruitment Status : Completed
First Posted : February 8, 2013
Results First Posted : June 10, 2019
Last Update Posted : June 10, 2019
Sponsor:
Information provided by (Responsible Party):
Dmitry Khvan, Meshalkin Research Institute of Pathology of Circulation

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

Condition or disease Intervention/treatment Phase
Ascending Aortic Aneurism Aortic Valve Insufficiency Procedure: Aortic Root Reimplantation Procedure Procedure: Aortic Valve Reimplantation Procedure Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Superiority Trial of Aortic Root Reimplantation Procedure Versus Aortic Valve Reimplantation Procedure
Actual Study Start Date : January 2011
Actual Primary Completion Date : November 20, 2015
Actual Study Completion Date : November 20, 2015

Arm Intervention/treatment
Active Comparator: Aortic Root Reimplantation Procedure
Aortic Root Reimplantation Procedure
Procedure: Aortic Root Reimplantation Procedure
Modified Florida Sleeve.
Other Name: Modified Florida Sleeve.

Active Comparator: Aortic Valve Reimplantation Procedure
Aortic Valve Reimplantation Procedure
Procedure: Aortic Valve Reimplantation Procedure
David I
Other Name: David I




Primary Outcome Measures :
  1. 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..


Secondary Outcome Measures :
  1. Survival (Percentage, Kaplan-Meier) [ Time Frame: up to 4 yeras ]
    Estimated percentage of alive participants for 4 years after treatment.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01787604


Locations
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Russian Federation
Meshalkin State Research Institute of Circulation Pathology
Novosibirsk, Russian Federation, 630055
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation

Publications of Results:
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

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Responsible Party: Dmitry Khvan, cardiac surgeon, Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT01787604     History of Changes
Other Study ID Numbers: STAR
First Posted: February 8, 2013    Key Record Dates
Results First Posted: June 10, 2019
Last Update Posted: June 10, 2019
Last Verified: March 2019

Keywords provided by Dmitry Khvan, Meshalkin Research Institute of Pathology of Circulation:
Valve-sparing
Valve repair

Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Valve Insufficiency
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Heart Valve Diseases
Heart Diseases