NCT00267995

Brief Summary

The Ross procedure has become the surgery of choice for aortic valve replacement in children. This consists of taking a child's own pulmonary valve (the autograft) and replacing the child's diseased aortic valve with the autograft. At times, this can involve either enlarging or reducing the diameter of the aortic annulus to make the valve fit properly. The patient's own pulmonary valve is then replaced, most typically with a human heart valve (a homograft). There has been some concern in the literature that as time goes on, the autograft will dilate and the patient will develop progressive aortic insufficiency. Since 1994, we have performed almost 50 Ross procedures in children and young adults. Contrary to many reports from the literature, we have not recognized a problem with autograft enlargement and progressive aortic insufficiency. One thing that we have done differently from other centers is that we have modified the insertion technique of the autograft into the native aortic root. This involves a second buttressing suture layer. Not only does this have the immediate effect of reducing bleeding complications, we postulate that it has the long-term effect of stabilizing the autograft and preventing aortic root dilatation. We hypothesize that this proximal buttressing technique for the Ross procedure has a two-fold benefit. Firstly, it reduces the amount of bleeding in the postoperative period. Secondly, it prevents late autograft root dilatation.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1994

Completed
11.1 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2005

Completed
Last Updated

July 6, 2011

Status Verified

May 1, 2007

First QC Date

December 20, 2005

Last Update Submit

July 5, 2011

Conditions

Congenital Disorders

Keywords

PediatriccardiacRoss procedureAortic valve replacementProximal buttressing technique

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Retro chart review

You may qualify if:

  • Ross procedure with and without Proximal butressing technique
  • Ross procedure between 12.1994 and 8.2003

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Kirk R. Kanter, MD

    Children's Healthcare of Atlanta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 20, 2005

First Posted

December 22, 2005

Study Start

December 1, 1994

Last Updated

July 6, 2011

Record last verified: 2007-05

Locations

US(1)