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Study of Aortic Root Reimplantation Procedure (STAR)

This study is currently recruiting participants.
Verified January 2016 by Dmitry Khvan, Meshalkin Research Institute of Pathology of Circulation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01787604
First Posted: February 8, 2013
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Dmitry Khvan, Meshalkin Research Institute of Pathology of Circulation
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Superiority Trial of Aortic Root Reimplantation Procedure Versus Aortic Valve Reimplantation Procedure

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

Primary Outcome Measures:
  • All cause aortic valve replacement [ Time Frame: 12, 24,36 months after procedure ]
    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 ]
  • mortality [ Time Frame: 12, 24,36 months after procedure ]

Estimated Enrollment: 64
Study Start Date: January 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, MD         
Sub-Investigator: Dmitry A Sirota, MD         
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
First Submitted: January 30, 2013
First Posted: February 8, 2013
Last Update Posted: October 12, 2017
Last Verified: January 2016

Keywords provided by Dmitry Khvan, 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