Congenital DisordersNCT00268034
Left Ventricular Aneurysms in Children
An observational study of Congenital Disorders, run by Children's Healthcare of Atlanta at 1 site in United States.
Trial summary
Collect data to support "standard of care possibility" of extracardiac repair with closure of intracavitary communication and plication of the aneurysm as probably safest surgical repair for left ventricular aneurysms. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Congenital Disorders
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2002to 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
- aneurysms between 6.30.2002 and 6.30.2004
Who cannot join
- those children who do no 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
Collect data to support "standard of care possibility" of extracardiac repair with closure of intracavitary communication and plication of the aneurysm as probably safest surgical repair for left ventricular aneurysms.
Read the detailed description
Ventricular aneurysms in the pediatric population are rare and no standardized method of treatment exists.
We plan on reviewing five patient charts between the dates of 6.30.02 and 6.30.04 as to causes of aneurysms. The patient charts selected will be in the following "aneurysm categories":
Mostly occur after:
Ross/Ross-Konno procedures modified Rastelli-type interventricular tunnels repeated resections of subaortic stenosis and possibly after: myocardial ischemia trauma drainage of abscess in infective endocarditis progressive herniation of endocardium mostly located: in LV outflow tract
We plan on collecting echocardiograms and / or cardiac catheterizations data in order to confirm the diagnosis of an aneurysm. We will also collect the following information:
- Procedures including the dates performed
- Medications
- Physical Exam Findings
- Weight
- Gestational Age
- Outcome
- Conditions
- Congenital Disorders
- Keywords
- pediatric, cardiac, aneurysms, left ventricular aneurysms, surgical repair for LV aneurysms
- Medical subject headings
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Aneurysm
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 startJun 2002
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
- 5 participants
Sponsor and investigators
- Lead sponsor
- Children's Healthcare of Atlanta
- Sponsor type
- University, hospital or other
- Investigators
- Kirk R Kanter, MD, Principal investigator, Children's Healthcare of Atlanta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00268034
- Sponsor's protocol ID
- 04-073
- 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
- Left Ventricular Aneurysms in Children
- ClinicalTrials.gov ID
- NCT00268034
- Acronym / sponsor ID
- 04-073
- Conditions
- Congenital Disorders
- Keywords
- pediatric, cardiac, aneurysms, left ventricular aneurysms, surgical repair for LV aneurysms
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 5 participants
- Lead sponsor
- Children's Healthcare of AtlantaUniversity, hospital or other
- Study start
- Jun 2002
- 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.
Collect data to support "standard of care possibility" of extracardiac repair with closure of intracavitary communication and plication of the aneurysm as probably safest surgical repair for left ventricular aneurysms.
Detailed description
Ventricular aneurysms in the pediatric population are rare and no standardized method of treatment exists.
We plan on reviewing five patient charts between the dates of 6.30.02 and 6.30.04 as to causes of aneurysms. The patient charts selected will be in the following "aneurysm categories":
Mostly occur after:
Ross/Ross-Konno procedures modified Rastelli-type interventricular tunnels repeated resections of subaortic stenosis and possibly after: myocardial ischemia trauma drainage of abscess in infective endocarditis progressive herniation of endocardium mostly located: in LV outflow tract
We plan on collecting echocardiograms and / or cardiac catheterizations data in order to confirm the diagnosis of an aneurysm. We will also collect the following information:
- Procedures including the dates performed
- Medications
- Physical Exam Findings
- Weight
- Gestational Age
- Outcome
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 (1 listed)
- aneurysms between 6.30.2002 and 6.30.2004
Key exclusion criteria (1 listed)
- those children who do no 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
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 1 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.