Study of Aortic Root Reimplantation Procedure (STAR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 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: March 7, 2014
Last verified: March 2014

January 30, 2013
March 7, 2014
January 2011
December 2014   (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
Non-inferiority Trial of Aortic Root Reimplantation Procedure Versus Aortic Valve Reimplantation Procedure

Authors hypothesize that there is no difference in aortic insufficiency more than grade 2+ between the standard aortic valve reimplantation procedure and aortic root reimplantation procedure more than 15%.

A single blind prospective randomized non-inferiority study is conducted. Our hypothesis is that there is no difference in aortic insufficiency more than grade 2+ between the standard aortic valve reimplantation procedure and aortic root reimplantation procedure more than 15%. If there is truly no difference between groups (Aortic Root Reimplantation Procedure and Aortic Valve Reimplantation Procedure), then total 40 patients for both groups are required to be 70% sure that the upper limit of a one-sided 95% confidence interval (or equivalently a 90% two-sided confidence interval) would exclude a difference in favour of the Aortic Valve Reimplantation Procedure of more than 14%. 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2015
December 2014   (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
March 2014

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