Heart Disease, CongenitalNCT00276237
Outcomes Following Pulmonary Valve Replacement in Adults
An observational study of Heart Disease, Congenital and Pulmonary Valve Replacement, run by Emory University at 2 sites in United States.
Trial summary
One of the most common residual lesions in adult survivors of pediatric cardiac surgery is pulmonary valve disease, particularly regurgitation. Multiple studies have demonstrated that placement of a pulmonary valve in such patients, results in improved ventricular function and resolution of symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Disease, Congenital, Pulmonary Valve Replacement
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2005to Nov 2005
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
Emory Healthcare System
Atlanta, Georgia, 30322
About this study
Official title: Review of Outcomes Following Pulmonary Valve Replacement for Congenital Heart Disease in Adults
One of the most common residual lesions in adult survivors of pediatric cardiac surgery is pulmonary valve disease, particularly regurgitation.
Multiple studies have demonstrated that placement of a pulmonary valve in such patients, results in improved ventricular function and resolution of symptoms. However, the optimal prosthetic valve for use in the pulmonary position has not been defined. There are essentially three alternatives available: the stented bioprosthetic valve, stentless bioprosthetic "tube" grafts used to replace the entire right ventricular outflow tract and mechanical valves.
Read more
All three of these valve options have been used in adults with congenital heart disease at Emory Healthcare and at Children's Healthcare of Atlanta at Egleston.
The goal of this study is to evaluate and compare the indications and short and mid-term outcomes for these alternative therapies.
- Keywords
- Congenital Heart Disease, Pulmonary Valve Replacement
- Medical subject headings
- Heart Defects, Congenital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2006 (estimated)
- Study startJul 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Disease, CongenitalStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Time perspective
- Prospective
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Kogon, Emory University
- Investigators
- Paul M Kirshbom, MD, Principal investigator, Emory University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00276237
- Sponsor's protocol ID
- 0668-2005
- Status last verified
- Nov 2013
- First submitted
- 12 Jan 2006
- Last updated
- 26 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Review of Outcomes Following Pulmonary Valve Replacement for Congenital Heart Disease in Adults
- ClinicalTrials.gov ID
- NCT00276237
- Acronym / sponsor ID
- 0668-2005
- Keywords
- Congenital Heart Disease, Pulmonary Valve Replacement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Jul 2005
- Study completion
- Nov 2005 (actual)
- First posted
- 13 Jan 2006 (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.
One of the most common residual lesions in adult survivors of pediatric cardiac surgery is pulmonary valve disease, particularly regurgitation.
Multiple studies have demonstrated that placement of a pulmonary valve in such patients, results in improved ventricular function and resolution of symptoms. However, the optimal prosthetic valve for use in the pulmonary position has not been defined. There are essentially three alternatives available: the stented bioprosthetic valve, stentless bioprosthetic "tube" grafts used to replace the entire right ventricular outflow tract and mechanical valves.
All three of these valve options have been used in adults with congenital heart disease at Emory Healthcare and at Children's Healthcare of Atlanta at Egleston.
The goal of this study is to evaluate and compare the indications and short and mid-term outcomes for these alternative therapies.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2013.
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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.
Paul M Kirshbom, MD principal investigator
Emory University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Disease, Congenital and Pulmonary Valve Replacement, run by Emory University at 2 sites 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 0 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: finished, as of the sponsor's last update on 26 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 26 Nov 2013.