Overview

This trial is active, not recruiting.

Conditions ascending aorta aneurism, aortic insufficiency
Treatment aortic valve reimplantation using valsalva prosthesis
Sponsor Meshalkin Research Institute of Pathology of Circulation
Start date January 2007
End date December 2012
Trial size 60 participants
Trial identifier NCT01456975, EVAPRO

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Experimental)
Reimplantation procedure using Valsalva prosthesis
aortic valve reimplantation using valsalva prosthesis Gelweave Vascutek Valsalva
Aortic valve reimplantation (David procedure)using Valsalva prosthesis

Primary Outcomes

Measure
all causes of aortic valve replacement
time frame: before discharging (average of 2 weeks after surgery)

Secondary Outcomes

Measure
all causes of death after procedure
time frame: 6, 12, 24,36,48,60,72, 84, 96 months after procedure

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Reimplantation Procedure for Surgical Treatment of Ascending Aorta Aneurism With Concomitant Aortic Valve Insufficiency
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Meshalkin Research Institute of Pathology of Circulation.