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

Conditions

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

  • Russian Federation
      • Novosibirsk, Russian Federation, 630055
        • Meshalkin State Research Institute of Circulation Pathology

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
Procedure: Aortic Root Reimplantation Procedure
Modified Florida Sleeve.
Other Names:
  • Modified Florida Sleeve.
Active Comparator: Aortic Valve Reimplantation Procedure
Procedure: Aortic Valve Reimplantation Procedure
David I
Other Names:
  • David I

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.

Sponsor

Meshalkin Research Institute of Pathology of Circulation

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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