Congenital DisordersNCT00266916
Percutaneous Interventions in Adults With CHD
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 study is to determine the clinical benefits of percutaneous intervention to improve pulmonary blood flow on oxygen saturations, symptoms, exercise tolerance and hematocrit in patients with complex cyanotic congenital heart disease who are not candidates for surgical repair. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congenital Disorders
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1996to Aug 2006
- 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
- greater than 18 years of age
- complex cyanotic heart disease
- oxygen saturation prior to intervention < 90%
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: Percutaneous Interventions in Adults With Complex Cyanotic Congenital Heart Disease
The primary objective of this study is to determine the clinical benefits of percutaneous intervention to improve pulmonary blood flow on oxygen saturations, symptoms, exercise tolerance and hematocrit in patients with complex cyanotic congenital heart disease who are not candidates for surgical repair.
Read the detailed description
This is a single center, retrospective study of adult patients with a diagnosis of un-repaired complex cyanotic congenital heart disease including Eisenmenger's Syndrome, single ventricle, pulmonary atresia with aorticopulmonary collaterals, complete atrio-ventricular canal defects, double inlet left ventricle, heterotaxy syndromes and truncus arteriosus. Patients with surgically placed systemic to pulmonary artery shunts will be included.
Although generally incompatible with adult survival, rare patients with un-operated or palliated complex cyanotic congenital heart defects (CCHD) survive well into adulthood. Symptoms related to poor pulmonary blood flow and/ or increasing pulmonary vascular resistance progress with advancing age. Percutaneous interventions to improve symptoms and relieve hypoxemia have not been previously reported in adult patients with complex cyanotic congenital heart disease. Percutaneous interventions in patients with cyanotic congenital heart disease may be generally broken down into three types: percutaneous occlusion of shunt lesions, percutaneous balloon valvotomy or valvuloplasty, and balloon angioplasty and stenting of vascular structures (1). Percutaneous interventions for occluded or stenotic systemic to pulmonary artery shunts in childhood have been described (2,3). However, procedures to improve pulmonary blood flow in adults with CCHD have not previously been described.
- Conditions
- Congenital Disorders
- Keywords
- adult, congenital heart disease, percutaneous occlusion, percutaneous balloon valvotomy, balloon angioplasty, complex cyanotic congenital heart defects (CCHD)
- Medical subject headings
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities, 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 posted20 Dec 2005 (estimated)
- Study startJan 1996
- Study completionAug 2006
Why it stopped: data collection sufficient
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
- 9 participants
Sponsor and investigators
- Lead sponsor
- Children's Healthcare of Atlanta
- Sponsor type
- University, hospital or other
- Investigators
- Wendy M. Book, MD, Principal investigator, Children's Healthcare of Atlanta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00266916
- Sponsor's protocol ID
- 05-138
- Status last verified
- May 2007
- First submitted
- 19 Dec 2005
- Last updated
- 23 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Interventions in Adults With Complex Cyanotic Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT00266916
- Acronym / sponsor ID
- 05-138
- Conditions
- Congenital Disorders
- Keywords
- adult, congenital heart disease, percutaneous occlusion, percutaneous balloon valvotomy, balloon angioplasty, complex cyanotic congenital heart defects (CCHD)
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: data collection sufficient
- Enrolment
- 9 participants
- Lead sponsor
- Children's Healthcare of AtlantaUniversity, hospital or other
- Study start
- Jan 1996
- Study completion
- Aug 2006
- First posted
- 20 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 study is to determine the clinical benefits of percutaneous intervention to improve pulmonary blood flow on oxygen saturations, symptoms, exercise tolerance and hematocrit in patients with complex cyanotic congenital heart disease who are not candidates for surgical repair.
Detailed description
This is a single center, retrospective study of adult patients with a diagnosis of un-repaired complex cyanotic congenital heart disease including Eisenmenger's Syndrome, single ventricle, pulmonary atresia with aorticopulmonary collaterals, complete atrio-ventricular canal defects, double inlet left ventricle, heterotaxy syndromes and truncus arteriosus. Patients with surgically placed systemic to pulmonary artery shunts will be included.
Although generally incompatible with adult survival, rare patients with un-operated or palliated complex cyanotic congenital heart defects (CCHD) survive well into adulthood. Symptoms related to poor pulmonary blood flow and/ or increasing pulmonary vascular resistance progress with advancing age. Percutaneous interventions to improve symptoms and relieve hypoxemia have not been previously reported in adult patients with complex cyanotic congenital heart disease. Percutaneous interventions in patients with cyanotic congenital heart disease may be generally broken down into three types: percutaneous occlusion of shunt lesions, percutaneous balloon valvotomy or valvuloplasty, and balloon angioplasty and stenting of vascular structures (1). Percutaneous interventions for occluded or stenotic systemic to pulmonary artery shunts in childhood have been described (2,3). However, procedures to improve pulmonary blood flow in adults with CCHD have not previously been described.
Study design
- Observational model
- Defined population
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- greater than 18 years of age
- complex cyanotic heart disease
- oxygen saturation prior to intervention < 90%
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 (reason given: data collection sufficient). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 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.
Wendy M. Book, 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 3 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 23 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 (reason given: data collection sufficient). 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 23 May 2007.