NCT01456975

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

September 27, 2011

Completed
24 days until next milestone

First Posted

Study publicly available on registry

October 21, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

September 23, 2015

Status Verified

September 1, 2015

Enrollment Period

5.9 years

First QC Date

September 27, 2011

Last Update Submit

September 21, 2015

Conditions

Ascending Aorta AneurismAortic Insufficiency

Keywords

Ascending aorta aneurismAortic insufficiency

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (1)

  • all causes of death after procedure

    6, 12, 24,36,48,60,72, 84, 96 months after procedure

Study Arms (1)

Valsalva

EXPERIMENTAL

Reimplantation procedure using Valsalva prosthesis

Procedure: Aortic valve reimplantation using Valsalva prosthesis

Interventions

Aortic valve reimplantation using Valsalva prosthesisPROCEDURE

Aortic valve reimplantation (David procedure)using Valsalva prosthesis

Also known as: Gelweave Vascutek Valsalva
Valsalva

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Aortic annulus more than 30 mm
  • Aortic cusps destruction
  • Critical aortic cusps elongation
  • Aortic root dissection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dmitry A. Sirota

Novosibirsk, 630055, Russia

Location

MeSH Terms

Conditions

Aortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2011

First Posted

October 21, 2011

Study Start

January 1, 2007

Primary Completion

December 1, 2012

Study Completion

January 1, 2017

Last Updated

September 23, 2015

Record last verified: 2015-09

Locations

RU(1)