Study of Aortic Root Reimplantation Procedure (STAR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by Meshalkin Research Institute of Pathology of Circulation
Sponsor:
Information provided by (Responsible Party):
Dmitry Khvan, Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier:
NCT01787604
First received: January 30, 2013
Last updated: June 18, 2015
Last verified: June 2015

January 30, 2013
June 18, 2015
January 2011
December 2015   (final data collection date for primary outcome measure)
All cause aortic valve replacement [ Time Frame: 12, 24,36 months after procedure ] [ Designated as safety issue: No ]
Aortic insufficiency (AI) measured by echocardiography. If AI more than 2+, aortic valve replacement performed
Same as current
Complete list of historical versions of study NCT01787604 on ClinicalTrials.gov Archive Site
  • survival [ Time Frame: 12, 24,36 months after procedure ] [ Designated as safety issue: No ]
  • mortality [ Time Frame: 12, 24,36 months after procedure ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Aortic Root Reimplantation Procedure
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.

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 30 patients and Aortic Valve Reimplantation Procedure group consists of 30 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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Ascending Aortic Aneurism
  • Aortic Valve Insufficiency
  • Procedure: Aortic Root Reimplantation Procedure
    Modified Florida Sleeve.
    Other Name: Modified Florida Sleeve.
  • Procedure: Aortic Valve Reimplantation Procedure
    David I
    Other Name: David I
  • Active Comparator: Aortic Root Reimplantation Procedure
    Aortic Root Reimplantation Procedure
    Intervention: Procedure: Aortic Root Reimplantation Procedure
  • Active Comparator: Aortic Valve Reimplantation Procedure
    Aortic Valve Reimplantation Procedure
    Intervention: Procedure: Aortic Valve Reimplantation Procedure
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
64
December 2016
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Dmitry Khvan +79069090505 dmhvan@mail.ru
Russian Federation
 
NCT01787604
STAR
No
Dmitry Khvan, Meshalkin Research Institute of Pathology of Circulation
Meshalkin Research Institute of Pathology of Circulation
Not Provided
Not Provided
Meshalkin Research Institute of Pathology of Circulation
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP