Extravalvular Procedure for Surgical Treatment of Ascending Aorta Aneurism

NCT ID: NCT01456975

Last Updated: 2015-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2017-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ascending Aorta Aneurism Aortic Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Valsalva

Reimplantation procedure using Valsalva prosthesis

Group Type EXPERIMENTAL

Aortic valve reimplantation using Valsalva prosthesis

Intervention Type PROCEDURE

Aortic valve reimplantation (David procedure)using Valsalva prosthesis

Interventions

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Aortic valve reimplantation using Valsalva prosthesis

Aortic valve reimplantation (David procedure)using Valsalva prosthesis

Intervention Type PROCEDURE

Other Intervention Names

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Gelweave Vascutek Valsalva

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meshalkin Research Institute of Pathology of Circulation

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dmitry A. Sirota

Novosibirsk, , Russia

Site Status

Countries

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Russia

Other Identifiers

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EVAPRO

Identifier Type: -

Identifier Source: org_study_id

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