Study of Aortic Root Reimplantation Procedure

Aortic Valve Insufficiency Clinical Trial

— STAR  

Official title:

Superiority Trial of Aortic Root Reimplantation Procedure Versus Aortic Valve Reimplantation Procedure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01787604
• Other study ID #: STAR
• Status: Completed
• Phase: N/A
• Start date: January 2011
• Est. completion date: November 20, 2015

Study information

• Verified date: March 2019
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: November 20, 2015
• Est. primary completion date: November 20, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Valve Insufficiency
• Ascending Aortic Aneurism

Intervention

Procedure:
• Aortic Root Reimplantation Procedure
Modified Florida Sleeve.
• Aortic Valve Reimplantation Procedure
David I

Locations

Country	Name	City	State
Russian Federation	Meshalkin State Research Institute of Circulation Pathology	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

References & Publications (2)

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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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom From Aortic Insufficiency More Than 2+ (Percentage, Kaplan-Meier)	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	Survival (Percentage, Kaplan-Meier)	Estimated percentage of alive participants for 4 years after treatment.	up to 4 yeras