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NCT00267995 · ClinicalTrials.gov registry record

Ross Aortic Valve Replacement Patients

A clinical trial, sponsored by Children's Healthcare of Atlanta.

Terminated
Registry status
75
Enrollment target

NCT00267995 is a clinical trial that was terminated before completion, run by Children's Healthcare of Atlanta. The registered enrollment target is 75 participants.

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The verdict

NCT00267995 was terminated before completion, sponsored by Children's Healthcare of Atlanta.

TERMINATED
Registry status
75 participants
Enrollment target

Study 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 Details

FieldValue
Enrollment Target 75 participants
Start Date 1994-12

Sponsor

Children's Healthcare of Atlanta

80 total trials

What the Registry Record Tells You About NCT00267995

The ClinicalTrials.gov registry entry for NCT00267995 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Healthcare of Atlanta, which has 80 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT00267995 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00267995 about?

NCT00267995 is a clinical study titled "Ross Aortic Valve Replacement Patients". 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...

What is the current status of trial NCT00267995?

This trial is currently terminated. The enrollment target is 75 participants. The study started on 1994-12.

Who is sponsoring clinical trial NCT00267995?

This trial is sponsored by Children's Healthcare of Atlanta, which has 80 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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