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
  Purpose

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


Condition Intervention Phase
Ascending Aortic Aneurism
Aortic Valve Insufficiency
Procedure: Aortic Root Reimplantation Procedure
Procedure: Aortic Valve Reimplantation Procedure
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Superiority Trial of Aortic Root Reimplantation Procedure Versus Aortic Valve Reimplantation Procedure

Further study details as provided by Meshalkin Research Institute of Pathology of Circulation:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 64
Study Start Date: January 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01787604

Contacts
Contact: Dmitry Khvan +79069090505 dmhvan@mail.ru

Locations
Russian Federation
Meshalkin State Research Institute of Circulation Pathology Recruiting
Novosibirsk, Russian Federation, 630055
Contact: Dmitry Khvan    +79069090505    dmhvan@mail.ru   
Principal Investigator: Dmitry Khvan         
Sub-Investigator: Dmitry Sirota         
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation
  More Information

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

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
Study First Received: January 30, 2013
Last Updated: June 18, 2015
Health Authority: Russia: Ministry of Health of the Russian Federation

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

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

ClinicalTrials.gov processed this record on September 02, 2015