Congenital DisordersNCT00268008
Children and Adolescents Receiving Mechanical and Prosthetic Valves
An observational study of Congenital Disorders, run by Children's Healthcare of Atlanta at 1 site in United States.
Trial summary
The primary objective of this retrospective study of valve replacement is to document long-term survival and occurrence of valve related complications such as described in the literature; anticoagulant related bleeding event , thromboembolic events, subacute bacterial endocarditis (SBE), structural failure or… Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Congenital Disorders
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1976to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Valve replacement in the mitral or aortic position
- replacement at Children's Healthcare of Atlanta
- replacement between 1976 and 2002
- implants may be mechanical, bio-prosthetic or homograft
Who cannot join
- those who do not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
About this study
Official title: Retrospective Review of Children and Adolescents Receiving Mechanical and Prosthetic Valves in the Aortic and Mitral Position 1976-2002
The primary objective of this retrospective study of valve replacement is to document long-term survival and occurrence of valve related complications such as described in the literature; anticoagulant related bleeding event , thromboembolic events, subacute bacterial endocarditis (SBE), structural failure or deterioration , valve thrombosis, explantation and reimplantation with reason, death and death cause, and cerebrovascular accidents either permanent or transient in nature.
Secondary to this is the presumption that mechanical valves have a superior "life expectancy " to bio-prosthetic valves. We plan to look at the time of freedom from re-implantation from different types of valves, factoring in patient age, size ,defect and risk factors.
The information learned from this study may benefit future patients who undergo the Ross procedure by increasing our knowledge of safer and/or more effective techniques.
Read the detailed description
Both Aortic and Mitral valves utilizing bio-prosthetic and/or mechanical valves have been placed in adults since the 1960s.The replacement of these valves in children and adolescents began some 10 years after the first adult valve replacement. The majority of valves replaced in the pediatric cohort are due to either stenosis (narrowing) or incompetancy of the native valve. Valvular stenosis in the pediatric patient is normally of congenital etiology, however, a small percentage can be acquired from an infectious process. Stenosis of a valve impedes blood flow through the native valve orifice. Ventricular enlargement, hemodynamic instability and /or other major organ congestion can ensue if left untreated. Dependant upon the severity of the stenosis and the onset of the dysfunction, intervention may be required at any age (newborn to adult). In order for patients to have adequate blood flow to the systemic circulation (the body), the diseased valve must be replaced. Children with native valve stenosis experience failure to thrive, frequent pneumonia, difficulty breathing and generally poor physical development.
If the stenosis is of a critical nature greatly affecting hemodynamics, infants require intervention in the first few days of life. In these patients, initially many of the stenotic valves can be opened in the heart catheterization lab with a procedure called a valvuloplasty. While this procedure does open the valve leaflet apparatus, close approximation of the leaflets is not achieved and a residual insufficiency or regurgitation is present. Most infant hearts can handle minimal resurgent volumes from the resulting cardiac chamber enlargement. It will be necessary to surgically replace the incompetent valve with a prosthetic valve as the child grows. If valvuloplasty is unsuccessful, surgical intervention is required to relive the valvular Stenosis and improve hemodynamics.
Heart valve insufficiency creates a resurgence of blood back into either the left atrium or ventricle causing increased cardiac workload and dilation of the respective chamber of the heart. Incompetence of the Aortic valve will eventually cause congestive heart failure and/or sudden death from arrhythmias.
The initial surgery is dependant on the size of the ventricle and any other concomitant defects the child may have. A ventricle that is too small to support circulation will not be changed by placement of a valve. These patients require staged surgeries for single ventricle palliative repairs. Two examples of congenital cardiac defects include aortic stenosis and cleft mitral valve. If the aortic valve is stenosed and both ventricles are of adequate size, a Ross procedure can be done, The Ross procedure uses the patient's resected native pulmonary valve and main pulmonary artery in place of the aortic valve and outflow tract. A cryo-preserved homograft is then placed in the native pulmonary artery position. This homograft can be implanted with or without a valve dependant upon the patient's size and/or native valve orifice. Mitral valve anomalies occur frequently in patients with Atrioventricular septal defects. With this congenital defect the mitral valve may be dysplastic, or has a cleft in the anterior valve leaflet. This affects the competency of the valve, allowing regurgitation of blood flow into the left atrium. This increased blood volume in the left atrium will eventually lead to pulmonary hypertension. Because of this risk , repair of Atrioventricular septal defect is normally done between the ages of six and twelve months. Repair of the mitral valve is done at that time, with the knowledge that mitral valve replacement will be likely in the child's future. Repair of a heart valve in a patient of any age is always preferable to replacement; in children this is especially true.
Availability of replacement valves in infant sizes are limited to bio-prosthetic or homograft. Cryo-preserved homografts are made from either porcine and cadaver valves. These are generally used for pediatric patients under the age of two years. Historically homografts develop a significant amount of stenosis/calcification at the suture site. In addition, as the child grows the homograft size remains fixed. Both problems require further replacement.
Implantation of mechanical valves in the older children and young adults is considered as a treatment alternative. However, mechanical valves have inherent complications secondary to the requirement of long-term anticoagulant therapy (blood thinners) and the risk of thromboembolic events. Structural malfunctions of the valve and growth of the patient result in the need for replacement of mechanical valves. Additionally, patient compliance and dosing management can be difficult to control.
- Conditions
- Congenital Disorders
- Keywords
- aortic valve replacement, mitral valve replacement, valvular stenosis, Ross procedure, Homograft valves, Bio-prosthetic valves, Mechanical valves
- Medical subject headings
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2005 (estimated)
- Study startJan 1976
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Retrospective
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Children's Healthcare of Atlanta
- Sponsor type
- University, hospital or other
- Investigators
- Kirk R. Kanter, MD, Principal investigator, Emory Univ. SOM Cardiothoracic Surgery of Children's Healthcare of Atlanta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00268008
- Sponsor's protocol ID
- 05-033
- Status last verified
- May 2007
- First submitted
- 20 Dec 2005
- Last updated
- 7 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Review of Children and Adolescents Receiving Mechanical and Prosthetic Valves in the Aortic and Mitral Position 1976-2002
- ClinicalTrials.gov ID
- NCT00268008
- Acronym / sponsor ID
- 05-033
- Conditions
- Congenital Disorders
- Keywords
- aortic valve replacement, mitral valve replacement, valvular stenosis, Ross procedure, Homograft valves, Bio-prosthetic valves, Mechanical valves
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 300 participants
- Lead sponsor
- Children's Healthcare of AtlantaUniversity, hospital or other
- Study start
- Jan 1976
- First posted
- 22 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this retrospective study of valve replacement is to document long-term survival and occurrence of valve related complications such as described in the literature; anticoagulant related bleeding event , thromboembolic events, subacute bacterial endocarditis (SBE), structural failure or deterioration , valve thrombosis, explantation and reimplantation with reason, death and death cause, and cerebrovascular accidents either permanent or transient in nature.
Secondary to this is the presumption that mechanical valves have a superior "life expectancy " to bio-prosthetic valves. We plan to look at the time of freedom from re-implantation from different types of valves, factoring in patient age, size ,defect and risk factors.
The information learned from this study may benefit future patients who undergo the Ross procedure by increasing our knowledge of safer and/or more effective techniques.
Detailed description
Both Aortic and Mitral valves utilizing bio-prosthetic and/or mechanical valves have been placed in adults since the 1960s.The replacement of these valves in children and adolescents began some 10 years after the first adult valve replacement. The majority of valves replaced in the pediatric cohort are due to either stenosis (narrowing) or incompetancy of the native valve. Valvular stenosis in the pediatric patient is normally of congenital etiology, however, a small percentage can be acquired from an infectious process. Stenosis of a valve impedes blood flow through the native valve orifice. Ventricular enlargement, hemodynamic instability and /or other major organ congestion can ensue if left untreated. Dependant upon the severity of the stenosis and the onset of the dysfunction, intervention may be required at any age (newborn to adult). In order for patients to have adequate blood flow to the systemic circulation (the body), the diseased valve must be replaced. Children with native valve stenosis experience failure to thrive, frequent pneumonia, difficulty breathing and generally poor physical development.
If the stenosis is of a critical nature greatly affecting hemodynamics, infants require intervention in the first few days of life. In these patients, initially many of the stenotic valves can be opened in the heart catheterization lab with a procedure called a valvuloplasty. While this procedure does open the valve leaflet apparatus, close approximation of the leaflets is not achieved and a residual insufficiency or regurgitation is present. Most infant hearts can handle minimal resurgent volumes from the resulting cardiac chamber enlargement. It will be necessary to surgically replace the incompetent valve with a prosthetic valve as the child grows. If valvuloplasty is unsuccessful, surgical intervention is required to relive the valvular Stenosis and improve hemodynamics.
Heart valve insufficiency creates a resurgence of blood back into either the left atrium or ventricle causing increased cardiac workload and dilation of the respective chamber of the heart. Incompetence of the Aortic valve will eventually cause congestive heart failure and/or sudden death from arrhythmias.
The initial surgery is dependant on the size of the ventricle and any other concomitant defects the child may have. A ventricle that is too small to support circulation will not be changed by placement of a valve. These patients require staged surgeries for single ventricle palliative repairs. Two examples of congenital cardiac defects include aortic stenosis and cleft mitral valve. If the aortic valve is stenosed and both ventricles are of adequate size, a Ross procedure can be done, The Ross procedure uses the patient's resected native pulmonary valve and main pulmonary artery in place of the aortic valve and outflow tract. A cryo-preserved homograft is then placed in the native pulmonary artery position. This homograft can be implanted with or without a valve dependant upon the patient's size and/or native valve orifice. Mitral valve anomalies occur frequently in patients with Atrioventricular septal defects. With this congenital defect the mitral valve may be dysplastic, or has a cleft in the anterior valve leaflet. This affects the competency of the valve, allowing regurgitation of blood flow into the left atrium. This increased blood volume in the left atrium will eventually lead to pulmonary hypertension. Because of this risk , repair of Atrioventricular septal defect is normally done between the ages of six and twelve months. Repair of the mitral valve is done at that time, with the knowledge that mitral valve replacement will be likely in the child's future. Repair of a heart valve in a patient of any age is always preferable to replacement; in children this is especially true.
Availability of replacement valves in infant sizes are limited to bio-prosthetic or homograft. Cryo-preserved homografts are made from either porcine and cadaver valves. These are generally used for pediatric patients under the age of two years. Historically homografts develop a significant amount of stenosis/calcification at the suture site. In addition, as the child grows the homograft size remains fixed. Both problems require further replacement.
Implantation of mechanical valves in the older children and young adults is considered as a treatment alternative. However, mechanical valves have inherent complications secondary to the requirement of long-term anticoagulant therapy (blood thinners) and the risk of thromboembolic events. Structural malfunctions of the valve and growth of the patient result in the need for replacement of mechanical valves. Additionally, patient compliance and dosing management can be difficult to control.
Study design
- Observational model
- Defined population
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Valve replacement in the mitral or aortic position
- replacement at Children's Healthcare of Atlanta
- replacement between 1976 and 2002
- implants may be mechanical, bio-prosthetic or homograft
Key exclusion criteria (1 listed)
- those who do not meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirk R. Kanter, MD principal investigator
Emory Univ. SOM Cardiothoracic Surgery of Children's Healthcare of Atlanta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Disorders, run by Children's Healthcare of Atlanta at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2007.