Extravalvular Procedure for Surgical Treatment of Ascending Aorta Aneurism (EPSTAAA)
Primary Purpose
Ascending Aorta Aneurism, Aortic Insufficiency
Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Aortic valve reimplantation using Valsalva prosthesis
Sponsored by
About this trial
This is an interventional treatment trial for Ascending Aorta Aneurism focused on measuring Ascending aorta aneurism, Aortic insufficiency
Eligibility Criteria
Inclusion Criteria:
- Aortic insufficiency 2+
- Ascending aorta size more than 5 cm
- Ascending aorta size more than 4,5 cm (Marfan syndrome)
- Good conditions of aortic cusps
Exclusion Criteria:
- Aortic annulus more than 30 mm
- Aortic cusps destruction
- Critical aortic cusps elongation
- Aortic root dissection
Sites / Locations
- Dmitry A. Sirota
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Valsalva
Arm Description
Reimplantation procedure using Valsalva prosthesis
Outcomes
Primary Outcome Measures
all causes of aortic valve replacement
Aortic insufficiency (AI) measured by echocardiography. If AI more than 2+, aortic valve replacement performed
Secondary Outcome Measures
all causes of death after procedure
Aortic insufficiency (AI) measured by echocardiography. If AI more than 2+, aortic valve replacement performed
Full Information
NCT ID
NCT01456975
First Posted
September 27, 2011
Last Updated
September 21, 2015
Sponsor
Meshalkin Research Institute of Pathology of Circulation
1. Study Identification
Unique Protocol Identification Number
NCT01456975
Brief Title
Extravalvular Procedure for Surgical Treatment of Ascending Aorta Aneurism
Acronym
EPSTAAA
Official Title
Reimplantation Procedure for Surgical Treatment of Ascending Aorta Aneurism With Concomitant Aortic Valve Insufficiency
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
January 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators expect that the using of prothesis with sinuses has more benefits for long term competence and condition of aortic valve than the using of straight prothesis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ascending Aorta Aneurism, Aortic Insufficiency
Keywords
Ascending aorta aneurism, Aortic insufficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Valsalva
Arm Type
Experimental
Arm Description
Reimplantation procedure using Valsalva prosthesis
Intervention Type
Procedure
Intervention Name(s)
Aortic valve reimplantation using Valsalva prosthesis
Other Intervention Name(s)
Gelweave Vascutek Valsalva
Intervention Description
Aortic valve reimplantation (David procedure)using Valsalva prosthesis
Primary Outcome Measure Information:
Title
all causes of aortic valve replacement
Description
Aortic insufficiency (AI) measured by echocardiography. If AI more than 2+, aortic valve replacement performed
Time Frame
before discharging (average of 2 weeks after surgery)
Secondary Outcome Measure Information:
Title
all causes of death after procedure
Description
Aortic insufficiency (AI) measured by echocardiography. If AI more than 2+, aortic valve replacement performed
Time Frame
6, 12, 24,36,48,60,72, 84, 96 months after procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aortic insufficiency 2+
Ascending aorta size more than 5 cm
Ascending aorta size more than 4,5 cm (Marfan syndrome)
Good conditions of aortic cusps
Exclusion Criteria:
Aortic annulus more than 30 mm
Aortic cusps destruction
Critical aortic cusps elongation
Aortic root dissection
Facility Information:
Facility Name
Dmitry A. Sirota
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
12. IPD Sharing Statement
Learn more about this trial
Extravalvular Procedure for Surgical Treatment of Ascending Aorta Aneurism
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