Extravalvular Procedure for Surgical Treatment of Ascending Aorta Aneurism

Aortic Insufficiency Clinical Trial

— EPSTAAA  

Official title:

Reimplantation Procedure for Surgical Treatment of Ascending Aorta Aneurism With Concomitant Aortic Valve Insufficiency

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01456975
• Other study ID #: EVAPRO
• Status: Active, not recruiting
• Phase: N/A
• First received: September 27, 2011
• Last updated: September 21, 2015
• Start date: January 2007
• Est. completion date: January 2017

Study information

• Verified date: September 2015
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics CommitteeRussia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: January 2017
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Aortic insufficiency 2+

2. Ascending aorta size more than 5 cm

3. Ascending aorta size more than 4,5 cm (Marfan syndrome)

4. Good conditions of aortic cusps

Exclusion Criteria:

1. Aortic annulus more than 30 mm

2. Aortic cusps destruction

3. Critical aortic cusps elongation

4. Aortic root dissection

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Insufficiency
• Aortic Valve Insufficiency
• Ascending Aorta Aneurism

Intervention

Procedure:
• Aortic valve reimplantation using Valsalva prosthesis
Aortic valve reimplantation (David procedure)using Valsalva prosthesis

Locations

Country	Name	City	State
Russian Federation	Dmitry A. Sirota	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all causes of aortic valve replacement	Aortic insufficiency (AI) measured by echocardiography. If AI more than 2+, aortic valve replacement performed	before discharging (average of 2 weeks after surgery)	Yes
Secondary	all causes of death after procedure	Aortic insufficiency (AI) measured by echocardiography. If AI more than 2+, aortic valve replacement performed	6, 12, 24,36,48,60,72, 84, 96 months after procedure	Yes