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Study of Aortic Root Reimplantation Procedure (STAR)

This study is currently recruiting participants.
Verified February 2013 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: February 6, 2013
Last verified: February 2013
History of Changes
  Purpose

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%.


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: Non-inferiority Trial of Aortic Root Reimplantation Procedure Versus Aortic Valve Reimplantation Procedure

Resource links provided by NLM:

U.S. FDA Resources

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: 40
Study Start Date: January 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (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 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.

  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
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

No publications provided

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: February 6, 2013
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:
Aneurysm
Aortic Aneurysm
Aortic Valve Insufficiency
Vascular Diseases
 Cardiovascular Diseases
Aortic Diseases
Heart Valve Diseases
Heart Diseases

ClinicalTrials.gov processed this record on May 16, 2013